Vascular closure devices and methods

ABSTRACT

Vascular closure assembly embodiments may be used to provide hemostasis at vascular puncture sites or the like. Such vascular puncture or access sites may be created during a variety of percutaneous or minimally invasive medical procedures.

RELATED APPLICATIONS

This application claims priority under 35 U.S.C. section 119(e) fromU.S. Provisional Patent Application No. 62/937,675 filed Nov. 19, 2019,by B. Hauck et al., titled “Vascular Closure Devices and Methods”, whichis incorporated by reference herein in its entirety.

BACKGROUND

In many percutaneous procedures, a catheter is inserted into an accesshole in a blood vessel, such as the femoral artery. Such percutaneousprocedures may include minimally invasive cardiovascular procedures, forexample, including balloon angioplasty procedures, atherectomyprocedures, cardiovascular stent deployment, heart valve replacement, aswell as others. During such procedures, a therapeutic catheter may beinserted, typically over a guidewire, directly into an artery, or thecatheter may be inserted through a vascular introducer sheath. When thetherapeutic procedure is complete, the physician generally removes thetherapeutic catheter and then removes the introducer sheath from thevessel (if one was used). The physician then must prevent or limit theamount of blood that leaks through the vascular access hole. Physicianscurrently use a number of methods to close the vascular access hole orotherwise limit bleeding post procedure from the access hole, such aslocalized external compression, suture-mediated closure devices, plugs,gels, foams and similar materials.

However, such closure procedures may be time consuming, and may consumea significant portion of the time of the procedure. In addition,existing methods are associated with complications such as hematoma orthromboses. Still further, some of such procedures, particularlysuture-mediated closure devices, are known to have high failure rates inthe presence of common vascular diseases such as atherosclerosis andcalcification.

SUMMARY

Some embodiments of a vascular closure assembly may include an actuatorassembly having an elongate housing with an inner lumen extending alongthe elongate housing to the distal end of the elongate housing. Theelongate housing may also have a distal section, and a plurality ofanchor deployer lumens. The actuator assembly may also include aplurality of anchor deployers, each anchor deployer being slidablydisposed within a respective anchor deployer lumen of the elongatehousing with each anchor deployer including a distal end which isconfigured to extend and spread distally and radially outward from thedistal section of the elongate housing. The vascular closure assemblymay also have an inner catheter assembly including an elongate shafthaving a proximal end, a distal end, a distal section, an axial lengththat is sufficient for the distal section to extend distally beyond thedistal end of the elongate housing when disposed in the inner lumenthereof, and an outer surface contour which is configured to be slidablydisposed within the inner lumen of the elongate housing. The innercatheter assembly may further include an inflatable balloon disposed onthe distal section of the elongate shaft in an axial position that canextend distally from the distal end of the elongate housing when theelongate shaft is disposed within the inner lumen of the elongatehousing. The inflatable balloon may have an interior volume incommunication with a balloon inflation lumen, the balloon inflationlumen extending along the elongate shaft from an inflation port which isdisposed in fluid communication with the interior volume of theself-inflating balloon to an inlet port which is disposed on theelongate shaft.

Some embodiments of a vascular closure assembly may include an actuatorassembly having a chassis portion with an outer shell forming aninterior volume disposed within the outer shell. The actuator assemblymay further include an elongate housing with a proximal end secured to adistal end of the chassis portion, a distal end extending away from thechassis portion, an inner lumen extending along the elongate housing tothe distal end of the elongate housing, a distal section, and aplurality of anchor deployer lumens. In some cases, each anchor deployerlumen may extend axially along the elongate housing and terminatedistally at a distal port disposed in the distal section of the elongatehousing. The actuator assembly may also include a plurality of anchordeployers, each anchor deployer being slidably disposed within arespective anchor deployer lumen of the elongate housing and including adistal end which is configured to extend and spread in a distal andradially outward direction from the distal section of the outer housing.For some embodiments, each anchor deployer may include a deployment rodwhich has an elongate resilient configuration with an axial lengthgreater than a transverse dimension thereof and a distal end thatextends from the distal section of the elongate housing upon distalaxial deployment. Each of the anchor deployers may also have an anchorwhich is removably secured to the distal end of the deployment rod, andwhich is configured to resist proximal retraction within tissue. Thevascular closure assembly may also include an inner catheter assemblyhaving an elongate shaft with a proximal end, a distal end, a distalsection, an axial length that is sufficient for the distal section toextend distally beyond the distal end of the elongate housing whendisposed in the inner lumen thereof, and an outer surface contour whichis configured to be slidably disposed within the inner lumen of theelongate housing. The inner catheter assembly may further include aninflatable balloon disposed on the distal section of the elongate shaftin an axial position that can extend distally from the distal end of theelongate housing when the elongate shaft is disposed within the innerlumen of the elongate housing. The inflatable balloon may have aninterior volume that is in fluid communication with a balloon inflationlumen.

Some embodiments of an actuator assembly may include a chassis portionhaving an outer shell with an interior volume disposed within the outershell. The actuator assembly may further include an elongate housingwith an axial length greater than a transverse dimension thereof, aproximal end secured to a distal end of the chassis portion, a distalend extending away from the chassis portion, and an inner lumenextending along the elongate housing to the distal end of the elongatehousing. The elongate housing may also include a distal section, afilament lumen that extends along the elongate housing and terminates ata distal port disposed in the distal section of the elongate housing,and a plurality of anchor deployer lumens. In some cases, each anchordeployer lumen may extend axially along the elongate housing andterminate distally at a distal port disposed in the distal section ofthe elongate housing. The actuator assembly may also have a plurality ofanchor deployers, each anchor deployer being slidably disposed within arespective anchor deployer lumen of the elongate housing and including adistal end which is configured to extend and spread distally andradially outward from the distal section of the elongate housing. Forsome embodiments, each anchor deployer may include a deployment rodwhich has an elongate resilient configuration with an axial lengthgreater than a transverse dimension and a distal end that extends fromthe distal section of the elongate housing upon distal axial deployment.The anchor deployers may also each have an anchor which is removablysecured to the distal end of the deployment rod. Each anchor deployermay also include a filament which is slidably disposed within thefilament lumen of the elongate housing and which has a distal end whichis secured to the anchor. The actuator assembly may also include afilament lock mechanism disposed at a distal end of the filament lumenand including a filament lock disposed in operative arrangement with thefilaments of the respective plurality of anchor deployers.

Some embodiments of a catheter assembly may include an elongate shafthaving a proximal end, a distal end, a distal section and a proximalchassis secured to the proximal end of the elongate shaft. The catheterassembly may also include a self-inflating balloon disposed on thedistal section of the shaft, the self-inflating balloon having a thincompliant shell material, an interior volume in communication with aballoon inflation lumen, the balloon inflation lumen extending along theelongate shaft from an inflation port which is disposed in fluidcommunication with the interior volume of the self-inflating balloon toan inlet port which is disposed on the elongate shaft at an axialposition which is distal of a distal end of the self-inflating balloon.In addition, the catheter assembly may include a balloon inflation valveconfigured to controllably open and close the balloon inflation lumen.

Some embodiments of a filament lock may include a tubular structure witha main body portion and a plurality of fingers extending proximally fromthe main body portion. In some cases, the fingers may be of sufficientaxial length and elastically biased towards a center longitudinal axisof the main body portion such that respective distal ends of the fingersare configured to be self-contracting from an expanded state to arelaxed state and clamp onto the filaments disposed within the innerlumen of the filament lock when the fingers are in the relaxed state. Inaddition, the fingers may be configured to be elastically spread to arelative transverse separation to the expanded state sufficient to fitonto an outer surface of a distal end of a filament tube.

Some embodiments of a method for vascular closure may include distallyadvancing a vascular closure assembly towards an access hole in a bloodvessel and a passage disposed in a tissue layer adjacent the bloodvessel. In some cases, the vascular closure assembly may be so advancedwhile an inner catheter assembly of the vascular closure assembly isdisposed within an inner lumen of an elongate housing of an actuatorassembly of the vascular closure assembly. In addition, the vascularclosure assembly may be so distally advanced with an inflatable balloonof the inner catheter assembly extending distally beyond the distal endof the elongate housing. The method may also include inflating theinflatable balloon until contact and hemostasis is established betweenan outer surface of the self-inflating balloon and a perimeter surfaceof the access hole in the blood vessel. The method may further includeaxially translating the actuator assembly over the inner catheterassembly while holding the inner catheter assembly in a fixed axialposition relative to the access hole in the blood vessel until a distalend of an elongate housing of the actuator assembly is disposed adjacentthe passage in the tissue layer. Thereafter, a plurality of anchordeployers may be deployed so as to extend in a distal and radiallyoutward direction away from a distal section of the elongate housing ofthe vascular closure assembly with an anchor deployer actuator. Theanchor deployers may further engage the tissue layer in positionsdisposed about the passage in the tissue layer with respective anchorsof the plurality of anchor deployers. The method may also includedrawing the anchors closer together by applying proximal tension to thefilaments secured to each of the anchors so as to draw the anchors andrespective portions of the tissue layer secured to each of the anchorstogether and thereby reduce the transverse dimension of the passage inthe tissue layer. For some embodiments, a filament lock may be deployedonto the filaments at the distal end of the elongate housing byactivating the filament lock mechanism while maintaining tension forceon the filaments with a tensioning spring.

Some embodiments of a vascular closure device may include a filamentlock having a tubular structure with a main body portion and a pluralityof fingers extending proximally from the main body portion. In somecases, the fingers may be of sufficient axial length and elasticallybiased towards a center longitudinal axis of the main body portion suchthat respective distal ends of the fingers are configured to beself-contracting from an expanded state to a relaxed state and clamponto the filaments disposed within the inner lumen of the filament lockwhen the fingers are in the relaxed state. In addition, the fingers maybe elastically spread in an outward radial direction to a relativetransverse separation to the expanded state sufficient to fit onto anouter surface of a distal end of a filament tube. The vascular closureassembly may further include the filament tube disposed within the innerlumen of the filament lock with the filament lock in the expanded stateand at least one filament disposed within the inner lumen of thefilament lock. The vascular closure assembly may also have a filamenttube actuator which is configured to axially withdraw the filament tubefrom within the inner lumen of the filament lock.

Some embodiments of a method for vascular closure may include distallyadvancing an actuator assembly until a distal end of an elongate housingof the actuator assembly is disposed adjacent a passage in a tissuelayer. The method may further include deploying a plurality of anchordeployers from the elongate housing in a distal and radially outwarddirection in an asymmetric pattern about a longitudinal axis of theelongate housing and engaging the tissue layer in positions disposedabout the passage in the tissue layer in an asymmetric deploymentpattern with respective anchors of the plurality of anchor deployers.The anchors may then be drawn closer together by applying tension tofilaments secured to each of the respective anchors so as to draw theanchors and respective portions of the tissue layer secured to each ofthe anchors together and thereby reducing a transverse dimension of thepassage in the tissue layer and then deploying a filament lock onto thefilaments at a distal end of the elongate housing while maintainingtension force on the filaments.

Certain embodiments are described further in the following description,examples, claims and drawings. These features of embodiments will becomemore apparent from the following detailed description when taken inconjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a vascular closure assembly embodimentthat includes an actuator assembly and an inner catheter assembly.

FIG. 2 is a perspective view of an inner catheter assembly embodiment ofthe vascular closure assembly of FIG. 1.

FIG. 3 is a cut away view of an actuator assembly embodiment of thevascular closure assembly of FIG. 1.

FIG. 4 is a transverse section view of the actuator assembly of FIG. 3taken along lines 4-4 of FIG. 3.

FIG. 5 is a partial cut away view of a chassis portion of the actuatorassembly of FIG. 1 showing an angular alignment mechanism embodiment andinner lumen of the actuator assembly.

FIG. 6 is a partial perspective view of the actuator assembly of FIG. 1showing the filament cutter in an undeployed state.

FIG. 7 is an enlarged elevation view of an inner catheter assemblyposition lock embodiment disposed on a proximal end of the chassisportion of the actuator assembly of FIG. 1 that includes a cam lockconfiguration.

FIG. 8 is an enlarged elevation view in partial section showing anembodiment of an inner catheter assembly position lock embodiment thatincludes a collet type configuration.

FIG. 9 is a transverse section view of the inner catheter assembly ofFIG. 1 taken along lines 9-9 of FIG. 1.

FIG. 10 is a transverse section view of the inner catheter assembly ofFIG. 1 taken along lines 10-10 of FIG. 1.

FIG. 11 is a view in longitudinal section of the proximal chassis of theinner catheter assembly of FIG. 2 taken along lines 11-11 of FIG. 2.

FIG. 12 is a cut away view of the actuator assembly of FIG. 1 shown withanchor deployer embodiments in a deployed state into a tissue layerdisposed above and adjacent a patient's blood vessel.

FIG. 12A is a schematic view in elevation of an actuator assemblyembodiment that includes a spring driven anchor deployer actuatorembodiment.

FIG. 13 is an elevation view of an anchor deployer carrier embodimentsecured to a proximal end of a plurality of deployment rods.

FIG. 14 is a cut away view of an actuator assembly embodiment of thevascular closure assembly of FIG. 1 shown with a filament tensioningmechanism partially activated and filaments partially tensioned.

FIG. 15 is a view in longitudinal section of a filament tensioningmechanism embodiment of the actuator assembly embodiment of FIG. 14taken along lines 15-15 of FIG. 14.

FIG. 16 is a transverse cross section view of the filament tensioningmechanism embodiment of FIG. 15 taken along lines 16-16 of FIG. 15.

FIG. 17 is a partial cut away view in perspective of the actuatorassembly of FIG. 1 illustrating a tensioning spring of a filamenttensioning mechanism and a filament cutter embodiment.

FIG. 18 is an enlarged view of the filament cutting mechanism of theactuator assembly embodiment of FIG. 17.

FIG. 19 shows a distal section of the elongate housing of the actuatorassembly of FIG. 1 illustrating the discharge axis angle of one of theanchor deployer lumens of the actuator assembly.

FIG. 20 is an elevation view in section of a tissue layer disposed overtwo blood vessels of a patient including an artery and a vein and adistal section of an elongate housing embodiment of an actuator assemblydisposed adjacent the tissue layer with the anchor deployers of theactuator assembly in a deployed state and engaged with the tissue layer.

FIG. 20A is a schematic view of a deployment pattern embodiment.

FIG. 21 is an elevation view in longitudinal section of the distalsection of the elongate housing of the actuator assembly of FIG. 1.

FIG. 22 is a cut away view of the chassis portion of the actuatorassembly of FIG. 1 illustrating a filament tube actuator embodimentsecured to a proximal portion of the filament tube.

FIG. 23 is an elevation view of a filament lock embodiment.

FIG. 24 is a transverse section view of the filament embodiment of FIG.23 taken along lines 24-24 of FIG. 23.

FIG. 25 is an elevation view of another filament lock embodiment.

FIG. 26 is an elevation view in longitudinal section of the filamentlock embodiment of FIG. 25 taken along lines 26-26 of FIG. 25.

FIG. 27 is a transverse section view of the filament lock embodiment ofFIG. 25 taken along lines 27-27 of FIG. 25.

FIG. 28 shows the filament lock embodiment of FIG. 27 in an enlargedexpanded state.

FIG. 29 is a perspective view of a distal section of an anchor deployerembodiment.

FIG. 30 is a perspective view of a distal section of another anchordeployer embodiment.

FIG. 31 is a perspective view of a distal portion of a deployment rodembodiment of the anchor deployer of FIG. 30.

FIG. 32 is a transverse cross section of the deployment rod embodimentand anchor embodiment of the anchor deployer of FIG. 30 taken alonglines 32-32 of FIG. 30.

FIG. 33 is a perspective view of a distal portion of an anchor deployerembodiment that includes a deployment needle.

FIG. 34 is an elevation view in longitudinal section of the anchordeployer of FIG. 33 taken along lines 34-34 of FIG. 33.

FIG. 35 is an elevation view of a distal section of an inner catheterassembly embodiment.

FIG. 36 is an enlarged view in longitudinal section of a distal portionan embodiment of an inner catheter assembly shown with the ballooninflation lumen in an opened state for self inflation of theself-inflating balloon.

FIG. 37 shows the inner catheter assembly embodiment of FIG. 36 with theballoon inflation lumen in a closed state to prevent self inflation ofthe self-inflating balloon and to optionally permit venting of theinterior volume of the self-inflating balloon.

FIG. 38 is an enlarged elevation view in longitudinal section of adistal portion of an inner catheter assembly embodiment with aself-inflating balloon embodiment thereof in an uninflated state and afoot extension thereof in a retracted state.

FIG. 39 shows the inner catheter assembly embodiment of FIG. 38 with theself-inflating balloon in an inflated state and the foot extensionthereof in an outwardly extended state after deployment thereof.

FIG. 40 is an enlarged view in longitudinal section of a distal portionan embodiment of an inner catheter assembly shown with the ballooninflation lumen thereof in a closed state to prevent inflation of theself-inflating balloon and to optionally permit venting of the interiorvolume of the self-inflating balloon.

FIG. 41 shows the inner catheter assembly embodiment of FIG. 40 with theballoon inflation lumen in an open state for inflation of theself-inflating balloon thereof.

FIG. 42 is an end view of an optional foot extension housing portion ofan elongate shaft of an inner catheter assembly embodiment.

FIG. 43 is an elevation view in longitudinal section of the footextension housing portion of FIG. 42 taken along lines 43-43 of FIG. 42.

FIG. 44 is a perspective view of a foot extension embodiment.

FIG. 45 is a lower perspective view of the foot extension embodiment ofFIG. 44 operatively coupled to the foot extension housing portion ofFIG. 43 and extending outwardly therefrom.

FIG. 46 is a perspective view of a distal section of the elongatehousing of the actuator assembly of FIG. 1 with anchor deployers thereofdeployed into the tissue layer disposed above blood vessels of thepatient.

FIG. 47 is a perspective cut away view of embodiments of a patient'sblood vessels including a section of an artery and a section of a vein.

FIG. 48 is a transverse section view of the patient's blood vessels ofFIG. 47 taken along lines 48-48 of FIG. 47.

FIGS. 49-61 illustrate an embodiment of a vascular closure methodutilizing the vascular closure assembly embodiment of FIG. 1.

The drawings are intended to illustrate certain exemplary embodimentsand are not limiting. For clarity and ease of illustration, the drawingsmay not be made to scale, and in some instances, various aspects may beshown exaggerated or enlarged to facilitate an understanding ofparticular embodiments.

DETAILED DESCRIPTION

As discussed above, after a percutaneous catheterization procedure orany other procedure that requires vascular access with an access hole ina blood vessel of a patient, the physician must typically address theissue of bleeding from the vascular access hole once the therapeutic ordiagnostic device or devices have been removed from the access hole inthe patient's blood vessel. Some suitable device and method embodimentsfor such procedures are discussed in U.S. patent application Ser. No.15/277,542, now U.S. Pat. No. 10,639,020, filed Sep. 27, 2016 and issuedMay 5, 2020, by Thomas Larzon, et al., entitled VASCULAR CLOSURE DEVICE,U.S. patent application Ser. No. 16/190,654, filed Nov. 14, 2018, byThomas Larzon, et al., entitled COLLAPSIBLE TUBE FOR HEMOSTASIS, andU.S. patent application Ser. No. 16/190,694, filed Nov. 14, 2018, byHenrik Nyman, et al., entitled TISSUE CLOSURE DEVICE, each of which isincorporated by reference herein in its entirety. Any of the features,dimensions or materials of the embodiments discussed in theseincorporated references may be combined with or substituted for anysuitable features, dimensions or materials of the device and methodembodiments discussed herein. In addition, the embodiments discussedherein may be used or combined with each other in any suitable manner.In particular, any of the features, dimensions or materials of any ofthe embodiments discussed herein may be combined with or substituted forany of the features, dimensions or materials of any other suitableembodiment discussed herein.

Some embodiments of vascular closure assemblies discussed herein may beuseful for addressing certain clinical issues that may arise during useof a vascular closure device, such as rapid deployment, convenience,ease of use, and the like. Some of the device embodiments may includetwo primary components directed to an actuator assembly (that mayoptionally include a handle portion) and an inner catheter assembly. Theinner catheter assembly may include a small blood return lumen toprovide an indication that the distal tip is in fluid communication withan interior lumen of a blood vessel, a foot extension for positioningagainst the anterior wall of a blood vessel and an inflatable balloonfor maintaining hemostasis during a vascular closure procedure. Althoughthe inner catheter assembly is frequently discussed herein as acomponent of a vascular closure assembly, in some cases, such innercatheter assembly embodiments may function as stand alone catheterassemblies having the same or similar features, dimensions andmaterials. The actuator embodiment may include a plurality of anchordeployers and associated anchors, including four or more such anchordeployers and associated anchors, or any other suitable number of anchordeployers, with filaments such as sutures each having distal end securedto one of the plurality of anchors. The anchors may be implanted and/orengaged in a tissue layer at locations circumferentially disposed aboutan access hole in a blood vessel by deployment rods actuated by anactuator lever on the actuator assembly. The actuator assembly may alsoinclude a spring for applying tension force to the filaments to closethe access hole, and a filament lock to hold the filaments in place oncethe connection to the actuator assembly is cut.

In general, during use of such embodiments, the operation of deviceembodiments to close an access hole may begin once the underlyingtherapeutic or diagnostic procedure is complete and generally while theguidewire used for the procedure is still in place. The actuatorassembly together with the inner catheter assembly may be first loadedover the guidewire, and then advanced into the access hole (whilehemostasis is maintained via manual compression) until a visible bloodreturn appears on the proximal end of the blood return lumen of theinner catheter assembly. A lever may then be activated to deploy thefoot extension, and the actuator assembly and inner catheter assemblyare pulled proximal until the foot extension engages with the anteriorwall of the blood vessel. Next, another lever may be actuated to open aballoon inflation valve to allow blood pressure to fill the inflatablehemostasis balloon, thereby providing temporary blood leakage control orhemostasis control at the access site. Manual compression may then bereduced or released.

The actuator assembly may then be slid distally over the inner catheterassembly until it is aligned with an insertion alignment mark, therebypositioning the nose tip of the actuator assembly the correct distancefrom the blood vessel and the tissue layer disposed above the bloodvessel, for example the fascia layer. An actuator lever on the actuatorassembly may be pulled next to deploy the anchor deployers andassociated anchors. Filament tension may then be applied by rotating thelarge knob at the base of the actuator assembly. The inflatable balloonmay then be withdrawn, allowing filament tension to fully close theaccess hole. Finally, the filament lock may be deployed by pulling asmall lever on the actuator assembly, and the suture filaments are cutby pressing a filament cutter button on the proximal aspect of theactuator assembly. The device may now be slid off the guidewire and skinwound closed in standard fashion.

Referring generally to FIGS. 1-6, an embodiment of a vascular closureassembly 10 that may be used for such a vascular closure procedure mayinclude an actuator assembly 12 having a chassis portion 14 with anouter shell 16 and an interior volume 18 disposed within the outer shell16. The actuator assembly 12 may further include an elongate housing 22having an axial length greater than a transverse dimension thereof, aproximal end 24 secured to a distal end 26 of the chassis portion 14,and a distal end 28 extending away from the chassis portion 14. Theelongate housing 22 also includes an inner lumen 32 extending along theelongate housing 22 to the distal end 28 of the elongate housing 22 asshown in FIG. 4, a distal section 34, a filament lumen 36 disposedwithin a filament tube 37 that extends along the elongate housing 22 asshown in FIG. 4 and that terminates at a distal port 38 disposed in thedistal section 34 of the elongate housing 22 as shown in FIG. 19-21. Theelongate housing 22 further includes and a plurality of anchor deployerlumens 42. Each anchor deployer lumen 42 may extend axially, along acurved or straight path, along the elongate housing 22 and terminatedistally at a distal port 44 disposed in the distal section 34 of theelongate housing 22. In some cases, a handle portion 46 of the actuatorassembly 12 may have an upper end 48 secured to the chassis portion 14.

The actuator assembly 12 may also include a plurality of anchordeployers 52 as shown in FIG. 4, each anchor deployer being slidablydisposed within a respective anchor deployer lumen 42 of the elongatehousing 22 and including a distal end 54 which is configured to extendand spread from the distal section 34 of the elongate housing 22 in adistal and radially outward orientation as shown in FIG. 29. For someembodiments, each anchor deployer 52 may include a deployment rod 56which has an elongate resilient configuration with an axial lengthgreater than a transverse dimension and a distal end 58 that extendsfrom the distal section 34 of the elongate housing 22 upon distal axialdeployment. An anchor 62 is removably or otherwise releasably secured tothe distal end 58 of the deployment rod 56. In some cases, a tubularstructure at the proximal end of the anchor embodiments 62 may beconfigured to slide over and mate with the distal end 58 of thedeployment rod 56 such that distally oriented force from the distal end58 of the deployment rod 56 is readily transferred to the anchor 62.However, the anchor 62 may also be configured to resist proximalretraction within tissue 64 once deployed as shown in FIG. 46 such thatthe distal end 58 of the deployment rod 56 slips out of the tubularstructure at the proximal end of the anchor embodiments 62 upon proximalretraction of the deployment rod 56 once the anchor 62 is deployed inthe tissue layer 64. A filament 66 may be slidably disposed within thefilament lumen 36 of the elongate housing 22 and include a distal end 68which is secured to the anchor 62. In addition, the actuator assembly 12may include a filament lock mechanism 72 disposed at a distal end 74 ofthe filament lumen 36 and filament tube 37, the filament lock mechanism72 including a filament lock 76 disposed in operative arrangement withthe filaments 66 of the respective plurality of anchor deployers 52 asshown in FIG. 21.

Some embodiments of the vascular closure assembly may also include aninner catheter assembly 78. The inner catheter assembly 78 may have anelongate shaft 82 including a proximal end 84, a distal end 86, a distalsection 88, an axial length that is sufficient for the distal section 88to extend distally beyond the distal end 28 of the elongate housing 22when disposed in the inner lumen 32 thereof. The inner catheter assembly78 may further include an outer surface contour which is configured tobe slidably disposed within the inner lumen 32 of the elongate housing22. A proximal chassis 92 may be secured to the proximal end 84 of theelongate shaft 82 of the inner catheter assembly 78. An inflatableballoon that may optionally be configured as a self-inflating balloon 94may be disposed on the distal section 88 of the elongate shaft 82 in anaxial position that can extend distally from the distal end 28 of theelongate housing 22 when the elongate shaft 82 is disposed within theinner lumen 32 of the elongate housing 22. The self-inflating balloon 94may include a wall portion 96 made from a thin compliant material and aninterior volume 98 in communication with a balloon inflation lumen 102as shown in FIGS. 9 and 10. The self-inflating balloon 94 may also havean outer surface contour that is configured to be slidably disposedwithin the inner lumen 32 of the elongate housing 22 when theself-inflating balloon 94 is in a deflated state.

The balloon inflation lumen 102 may extend along the elongate shaft 82from an inflation port 104 which is disposed within and in fluidcommunication with the interior volume 98 of the self-inflating balloon94 to an inlet port 106 which is disposed on the elongate shaft 82 at anaxial position which is distal of a distal end 108 of the self-inflatingballoon 94 as shown in FIGS. 35 and 36. Such an inner catheter assemblyembodiment 78 may also have a balloon inflation valve 112 which isconfigured to controllably open and close the balloon inflation lumen102. As discussed above, although the inner catheter assemblyembodiments 78 discussed herein are generally referred to as componentsof vascular closure assembly embodiments 10, the inner catheter assemblyembodiments 78 discussed herein may also function and be used as standalone catheter assembly embodiments 78 having the same or similarfeatures, dimensions and materials. Such stand alone catheter assemblyembodiments may be used for a variety of suitable indications, includingproviding hemostasis during procedures other than vascular closureprocedures such as coronary artery bypass graft procedures as well asothers.

The inner catheter assembly 78 of the vascular closure assembly 10 mayfurther include a guidewire lumen 114 as shown in FIGS. 9 and 10, theguidewire lumen 114 extending along the elongate shaft 82 to a distalguidewire port 116 disposed at the distal end 86 of the elongate shaft82 to accommodate a guidewire 117 as shown in FIGS. 35 and 36. The innercatheter assembly 78 may further include a blood return lumen 118 asshown in FIGS. 9 and 10. The blood return lumen 118 may extendproximally from a distal port 120 disposed on the distal section 88 ofthe elongate shaft 82 to a proximal port 122 of the blood return lumen118 disposed on the proximal chassis 92 as shown in FIG. 2. The distalport 120 may be disposed on the distal section 88 of the elongate shaft82 in an axial position that is proximal of the self-inflating balloon94 as also shown in FIG. 2. For embodiments of the inflatable balloon 94that are not configured as self-inflating, the balloon inflation lumenmay be disposed in fluid communication with an inflation pressure source(not shown) such as a syringe or other inflation pump rather than theinlet port 106.

For some embodiments, the self-inflating balloon 94 may have an outerprofile that is configured to self-expand from a compressed state whichis sized in transverse dimension to fit within the inner lumen 32 of theelongate housing 22, to an inflated state with an outer transversedimension which is larger than an outer transverse dimension of theelongate shaft 82. The self-inflating balloon 94 in an inflated statemay also be sized in transverse dimension and configured to completelyfill and plug an access hole 124 disposed in a wall portion 126 of ablood vessel 128 of a patient. The self-inflating balloon 94 may furtherinclude an outer contour in the inflated state having an elongate shapeor contour with a nominal axial length of the self-inflating balloon 94being greater than a transverse dimension of the self-inflating balloon94 when in the inflated state. In some cases, the self-inflating balloon94 in an inflated state may have an outer transverse dimension of about8 mm to about 15 mm and a nominal axial length of about 10 mm to about25 mm. In some instances, the wall portion 96 of the self-inflatingballoon 94 may have a thickness of about 0.02 mm to about 0.06 mm andmay be made from one or more materials including urethane, polyurethane,and silicone.

In some instances, it may be desirable to control inflation of theself-inflating balloon 94. As such, the balloon inflation valve 112 maybe configured to reversibly open and close the balloon inflation lumen102 as well as control the rate of flow of blood therethrough. Someembodiments of the balloon inflation valve 112 may include a plug 134which has an outer surface contour 136 that is matched to an innersurface contour 138 of the balloon inflation lumen 102 so as to preventa flow of fluid, such as blood, therethrough as shown in FIGS. 9, 10, 36and 37. This configuration also permits the plug 134 to be slidablydisposed within the balloon inflation lumen 102 between axial positionsthat block off a flow of blood from the inlet port 106 to the inflationport 104 as well as axial positions that allow a flow of blood throughthe balloon inflation lumen 102. An actuator rod 142 may have a distalend 144 secured to the plug 134 and a proximal end 146 operativelycoupled or otherwise secured to a balloon inflation lever 148 on theproximal chassis 92 as shown in FIG. 11. The balloon inflation lever 148may be slidable from a first position wherein the plug 134 is disposeddistal of the inflation port 104 of the balloon inflation lumen 102thereby blocking fluid communication between the inlet portion 106 andinflation port 104 of the balloon inflation lumen 102. The ballooninflation lever 148 may also be slidable to a second position, thesecond position being proximal of the first position and proximal of theinflation port 104 so as to allow fluid communication between the inletport 106 and inflation port 104 through the balloon inflation lumen 102.For some embodiments, the inlet port 106 may be disposed on the elongateshaft 82 distal of the distal end 108 of the self-inflating balloon 94.

In some cases during deployment of the self-inflating balloon 94, theself-inflating balloon 94 may be filled by fluid such as blood fromwithin the interior 150 of the blood vessel 128 and expand considerablyand assume a mushroom shaped configuration with the expanded head of themushroom configuration of the self-inflating balloon 94 being disposedoutside of the blood vessel 128 adjacent the access hole 124 in theblood vessel 128. Such an expansion of the outer surface 154 of theself-inflating balloon 94 may increase friction between a perimetersurface 156 of the access hole 124 in the blood vessel 128 and the outersurface 154 of the self-inflating balloon 94. In some instances, thisincreased friction may in turn hinder axial movement of theself-inflating balloon 94 with respect the access hole 124 as well asother structures such as moving the inner catheter assembly 78 withinthe interior lumen 150 of the blood vessel 128. In addition, in somecases the self-inflating balloon 94 may become trapped when beingwithdrawn into the distal end 158 of the inner lumen 32 of the elongatehousing 22 of the actuator assembly 12. As such, it may be useful toprovide a venting feature with regard to the interior volume 98 of theself-inflating balloon 94 that provides fluid communication between theinterior volume 98 of the self-inflating balloon 94 and the ambientatmospheric pressure disposed about the inner catheter assembly 78 ofthe vascular closure assembly 10 outside of the interior lumen 150 ofthe blood vessel 128 being treated. Such venting may typically becarried out while the balloon inflation lumen 102 disposed between ports104 and 106 is in a closed state preventing flow therethrough.

Given the foregoing, for some embodiments there may be a portion of theballoon inflation lumen 102 of the elongate shaft 82 that extendsproximal of the balloon inflation port 104 and this proximal portion maybe vented to the outside atmosphere. For such embodiments, when the plug134 of the balloon inflation valve 112 is disposed distal to the ballooninflation port 104 with fluid communication between the inlet port 106and inflation port 104 blocked, the inflation port 104 may thus bevented to the outside ambient atmosphere by the proximal portion of theballoon inflation lumen 102 in order to allow the interior volume 98 ofthe self-inflating balloon 94 to vent and deflate to a collapsed statewhen not being actively inflated. This arrangement may facilitate theaxial translation of the self-inflating balloon 94 within the bloodvessel lumen 150 as well as axial withdrawal of the self-inflatingballoon 94 into the inner lumen 32 of the elongate housing 22 when notbeing actively inflated.

Alternatively, a similar control of the inflation of the self-inflatingballoon 94 may be achieved with a balloon inflation valve embodiment 112that includes a cooperating pair of lamellas (or tubular members withrespective interacting lamella layer portions) configured with aplurality of ports that interact upon translation between two or morerelative axial positions to achieve the inflation and optional ventingfunctions of the balloon inflation valve features discussed above. Insome cases, a first lamella 162 disposed parallel to a second lamella164 may be disposed sitting tight together but free enough so that thelamellas 162, 164 may move axially in a distal and proximal direction inrelation to each other with one lamella such as the first lamella 162optionally being fixed in relation to the elongate shaft 82. In oneposition (when, for example, a foot extension 166 is stowed as shown inFIG. 40) the fluid communication between the blood vessel lumen 150 andthe interior volume 98 of the self-inflating balloon 94 may be blockedbut the fluid communication between the interior volume 98 of theself-inflating balloon 94 and venting to the ambient environment isopen. In a second position (for example, when the foot extension 166 isdeployed as shown in FIG. 41) the fluid communication between the bloodvessel lumen 150 and the interior volume 98 of the self-inflatingballoon 94 is open and the fluid communication between the interiorvolume 98 of the self-inflating balloon 94 and the ambient environmentis closed or otherwise blocked.

It may also be useful in some circumstances to combine the functions ofcertain elements of balloon inflation valve embodiments 112 and footextension actuator embodiments 168. For example, in some cases, theactuator rod 142 of the balloon inflation valve 112 discussed abovewhich is used to axially translate the plug 134 may also be used toactuate deployment of the foot extension 166 (discussed in more detailbelow) such that when the balloon inflation valve 112 is opened byproximally retracting the actuator rod 142, the foot extension 166 issimultaneously deployed by a distally extended portion of the actuatorrod 142 (not shown) that is operatively coupled to the foot extension166.

For some embodiments of such balloon inflation valve embodiments 112,the paired lamellas 162, 164 may include or otherwise be made fromportions of a tubular valve member 174 and the balloon inflation lumen102 of the elongate shaft 82 that are configured to be axially displacedrelative to each other by axial displacement of the tubular valve member174 with respect to the elongate shaft 82. The tubular valve member 174may have a first port 176 and a second port 178 coupled in fluidcommunication with each other that are also respectively positioned toalign with the inlet port 106 and inflation port 104 of the elongateshaft 82 when the tubular valve member 174 is disposed in the open axialposition as shown in FIG. 41 and positioned to not be aligned with theinlet port 106 and inflation port 104 when in the closed axial positionas shown in FIG. 40. In addition, a vent port 179 of the first lamella162 may be aligned with a third port 180 of the tubular valve member 174in this closed state which may be configured to provide venting from theinterior volume 98 of the self-inflating balloon 94 to the ambientatmosphere through the central lumen 181 of the tubular valve member 174which may extend to the proximal chassis 92 in in some cases. Flowthrough the central lumen 181 may be restricted by a seal 183 disposedwithin the central lumen 181 proximal of the second port 178 and distalof the first port 180. In some cases, an outer surface contour 182 ofthe tubular valve member 174 may be configured to have a close fit withan inside surface contour 138 of the balloon inflation lumen 102 of theelongate shaft 82. Such a close fit may be tight enough to prevent aflow of liquids such as blood between the outer surface contour 182 andinner surface contour 138 but spaced enough to allow relative axialdisplacement between the tubular valve member 174 and the elongate shaft82.

The inner catheter assembly 78 may further include the foot extension166 which is disposed on the elongate shaft 82 and which may beconfigured to extend outwardly from a retracted position wherein thefoot extension 166 is disposed substantially within a nominal outercontour 184 of the shaft 82 as shown in FIG. 38 to a deployed positionwherein an outer end 186 of the foot extension 166 extends radiallyoutward from the nominal outer contour 184 of the elongate shaft 82. Insome instances, the foot extension 166 may be disposed substantiallyperpendicular to a longitudinal axis 192 of the elongate shaft 82 whendeployed and extended. In some cases, the foot extension 166 may extendradially outward and proximally from the nominal outer contour 184 ofthe elongate shaft 82 forming an angle 185 of about 60 degrees to about90 degrees with the longitudinal axis 192 of the elongate shaft 82 asshown in FIG. 39. For some embodiments, the foot extension 166 may havean axial position on the elongate shaft 82 that leaves the footextension 166 disposed within the interior volume 98 of theself-inflating balloon 94. In other embodiments, the foot extension 166may be so disposed in a position that is axially coextensive with theself-inflating balloon 94, but not disposed within an interior volume 98of the self-inflating balloon 94. For such embodiments, theself-inflating balloon may include an open slot in the structure thereof(not shown) that is disposed about the foot extension 166. Such an openslot in the profile of the self-inflating balloon 94 may allow the footextension 166 to be disposed axially coextensive with the self-inflatingballoon 94 but still be deployed outwardly without interfering with thewall portion 96 of the self-inflating balloon 94 or any other suitableversion of the inflatable balloon embodiments.

For some embodiments, the foot extension 166 may be disposed at about anaxial mid-point 194 of the self-inflating balloon 94 to help ensureoverlap between the outer surface 154 of the self-inflating balloon 94and the perimeter surface 156 of the access hole 124 when theself-inflating balloon 94 is being deployed. For other embodiments, thefoot extension 166 may be disposed distal of the axial mid-point 194 ofthe self-inflating balloon 94 and proximal of the distal end 108 of theself-inflating balloon 94. For yet other embodiments, the foot extension166 may be disposed proximal of the axial mid-point 194 of theself-inflating balloon 94 and distal of a proximal end 196 of theself-inflating balloon 94 as shown in the embodiment of FIGS. 38 and 39.

The foot extension actuator 168 may be configured to change the state ofthe foot extension 166 between the retracted position and the deployedposition. In some cases, the foot extension actuator 168 may include afoot extension actuator rod 198 disposed within an actuator rod lumen204 of the elongate shaft 82 as shown in FIGS. 9-11. The foot extensionactuator rod 198 may have a distal end 199 operatively and/or pivotallysecured to the foot extension 166. The foot extension actuator rod 198may be configured to rotate or otherwise extend the foot extension 166in a generally outward radial direction upon axial translation of thefoot extension actuator rod 198. The foot extension actuator rod 198 mayfurther have a proximal end 206 secured to a foot actuation lever 208 onthe proximal chassis 92. The foot actuation lever 208 may have a firstposition wherein the foot extension 166 is disposed in the retractedposition, and a second position wherein the foot extension 166 isdisposed in the deployed position.

For some embodiments, the foot extension 166 may be operatively coupledto a foot extension housing 170 as shown in FIGS. 42-45. Such a footextension housing 170 may be configured to form a portion 82′ of theelongate shaft 82 of the inner catheter assembly 78. Some embodiments ofthe foot extension housing 170 and foot extension 166 may be configuredsuch that a curved slot 171 of the foot extension 166 mates with acorresponding curved rail 172 of the foot extension housing 170 whicheach have the same or similar radius of curvature. This sliding andmating coupling between the respective curved slot 171 and curved rail172 allows the outer end 186 of the foot extension 166 to rotate andextend radially outward as shown in FIG. 45 upon axial translation in aproximal direction of an inner end 187 of the foot extension 166 due tothe force applied thereto by the actuation of the foot extensionactuator 168 and axial translation of the associated foot extensionactuator rod 198. In other embodiments of the foot extension 166 andfoot extension actuator rod 198, the foot extension 166 may beconfigured to pivot about a pivot axis upon actuation and axialtranslation of the foot extension actuator rod 198 which may have adistal end thereof operatively and rotatably coupled to the footextension 166 at a position disposed radially outward from the pivotaxis as shown in the optional foot extension embodiments 166 of FIGS.38-41. The embodiments of the inner catheter assembly 78 shown in FIGS.38-41 may also include the foot extension housing 170 and associatedportion 82′ of the elongate shaft 82 as shown in FIGS. 42-45 anddiscussed above.

For some embodiments, the actuator assembly 12 may further include aninner catheter assembly position lock 212 as shown in FIG. 7. In someinstances, the inner catheter assembly position lock 212 may beconfigured to apply a frictional force to an outside surface 214 of theelongate shaft 82 of the inner catheter assembly 78 while the innercatheter assembly 78 is disposed within the inner lumen 32 of theelongate housing 22. The controllable application of this frictionalforce between the inner catheter assembly position lock 212 (which issecured to the chassis portion 14) and the inner catheter assembly 78may be used to releasably secure the inner catheter assembly 78 to theactuator assembly 12 and temporarily prevent axial displacement of theinner catheter assembly 78 with respect to the actuator assembly 12.This arrangement may be useful when it is desirable to axially translatethe actuator assembly 12 together with the inner catheter assembly 78,such as when the vascular closure assembly 10 is being initiallyadvanced into position adjacent the access hole 124 in the blood vessel128 as well as the passage 216 in the tissue layer 64 shown in FIG. 46disposed above the access hole 124. For some embodiments, the innercatheter assembly position lock 212 may include a pivoting lever 218having an offset cam 222 which is configured to intrude into the nominalcontour of the inner lumen 32 of the elongate housing 22 when disposedin a locked position with a degree of inward radial intrusion beingsufficient to contact the outer surface 214 of the inner catheterassembly 78 so as to resist axial translation of the inner catheterassembly 78 with respect to the actuator assembly 12 without causingpermanent deformation or damage to the inner catheter assembly 78. Inaddition, the offset cam 222 of the pivoting lever 218 may alsoconfigured to be clear of the nominal contour of the inner lumen 32 whendisposed in a released position so as to allow relative axialtranslation between the inner catheter assembly 78 and actuator assembly12.

Some embodiments of the inner catheter assembly position lock may alsoinclude a collet type inner catheter assembly position lock 212′ asshown in FIG. 8. For such an embodiment 212′, a threaded cap 219 mayinclude a tapered bore 220 that mates with an outer end of a flexibleslotted sleeve 221 that has an inner lumen disposed therethrough that issized to allow passage of the elongate shaft 82 of the inner catheterassembly 78 when the threaded cap 219 is loose, but clamp onto theoutside surface 214 of the inner catheter assembly 78 when the threadedcap 219 is tightened.

When determining the relative axial position between the inner catheterassembly 78 and actuator assembly 12, it may be useful to havepredetermined reference points on each of these structures that areeasily identifiable by a user. For example, in some cases the elongateshaft 82 may include an insertion alignment mark 224 disposed on anoutside surface 214 thereof that is visually identifiable by a user asshown in FIG. 2. The actuator assembly 12 may include a cooperatingproximal index 226 that is visually identifiable by a user as shown inFIG. 7. For such embodiments, an axial position of the deployed footextension 166, more specifically, an axial position of a notch of a “v”shape formed between the deployed foot extension 166 and the elongateshaft 82 on a proximal side of the foot extension 166 in a deployedstate (see FIGS. 39, 41 and 45) may be spaced by a predetermined axialseparation from the distal end 28 of the elongate housing 22 when theinsertion alignment mark 224 is axially aligned with the proximal index226. In some instances, the proximal index 226 and insertion alignmentmark 224 may be axially positioned on their respective structures suchthat this predetermined axial separation may be about 260 mm to about285 mm, more specifically, about 270 mm to about 275 mm.

In some cases, the elongate shaft 82 may further include a retractionalignment mark 228 disposed on an outside surface 214 thereof that isvisually identifiable by a user as shown in FIG. 2. For some suchembodiments, when the retraction alignment mark 228 is axially alignedwith the proximal index 226 this alignment may be used to indicate arelative axial relationship wherein the distal end 86 of the elongateshaft 82 of the inner catheter assembly 78 is disposed within the innerlumen 32 of the elongate housing 22. This arrangement may be useful whenit is important to determine that the distal end 86 of the elongateshaft 82 of the inner catheter assembly 78 is no longer disposed withinthe passage 216 adjacent the access hole 124 in the blood vessel 128. Insome cases, it may be desirable for the insertion alignment mark 224 andretraction alignment mark 228 are visually distinct from each other. Insome cases, the insertion alignment mark 224 may be a single band of acolor that is different than the color of an outside surface 214 of theelongate shaft 82 and the retraction alignment mark 228 may be of doubleband of the same or different color than that of the insertion alignmentmark 226.

In order to ensure proper angular alignment of the actuator assembly 12prior to deployment of the anchor deployers 52, it may be useful in someinstances to include an angular alignment mechanism 232 as part of thevascular closure assembly 10 as shown in FIG. 5. In some instances, theactuator assembly 12 of the vascular closure assembly 10 may include theangular alignment mechanism 232 that has a boss 234 that extends fromthe chassis portion 12 and a conical cavity 236 having a substantiallyshallow configuration disposed in the boss 234 that has an axis ofsymmetry 238 that forms a predetermined angle 242 with respect to thelongitudinal axis 244 of the elongate housing 22. The conical cavity 236may include a predetermined cone angle 246 defined between the innersurface 252 of the conical cavity and a plane that is perpendicular withthe axis of symmetry 238. The predetermined cone angle 246 may beconfigured to determine the sensitivity of the angular alignmentmechanism 232 with lower cone angles 246 being more sensitive to angularvariation and larger cone angles 246 being less sensitive to angularvariations.

A ball bearing 248 or similar spherical structure may be disposed in theconical cavity 236. The ball bearing 248 may be sized to rotate freelyon an inner surface 252 of the conical cavity 236 and remain centered atthe axis of symmetry 238 so long as the axis of symmetry 238 does notdeviate from an angular position that is perpendicular to level by anangle greater than the cone angle 246 of the conical cavity 236. Inother words, when the angular orientation of the angular alignmentmechanism 232 is correct, the ball bearing 248 sits in the center of theconical cavity 236 as shown in FIG. 5. If the alignment is incorrect,gravity causes the ball bearing 248 to roll away from the center of theconical cavity 236 due to the tapered bottom surface 252 of the conicalcavity 236. Although referred to herein as a conical cavity 236, anyother suitably configured cavity may also be used such as a sphericalcavity, parabolic cavity or the like. In addition, for the embodimentshown, the axis of symmetry 238 and longitudinal axis 244 liesubstantially in the same plane.

The angular alignment mechanism 232 may include a window 254 disposedover the conical cavity 236 to prevent escape of the ball bearing 248while still permitting visualization thereof. Embodiments of the angularalignment mechanism 232 may be specifically designed to be compatiblewith a variety of sterilization methods, such as e-beam, and ethyleneoxide (EtO), some of which would be unsuitable for a conventionalbubble-level alignment fixture. For some embodiments, the cone angle 246may be about 5 degrees to about 10 degrees. In addition, thepredetermined angle 242 formed between the axis of symmetry of theconical cavity and the longitudinal axis of the elongate housing may beabout 15 degrees to about 25 degrees.

Once the actuator assembly 12 and elongate housing 22 thereof areproperly positioned, deployment of the plurality of anchor deployers 52may be carried out by a variety of mechanisms and methods including ananchor deployer actuator 256 as shown in FIGS. 3, 12 and 13. For someembodiments, the anchor deployer actuator 256 of the vascular closureassembly 10 may include an anchor deployer carrier 258 which is slidablydisposed with respect the chassis portion 14 and which is operativelycoupled to a proximal section 262 of each of the plurality of deployerrods 56 as shown in FIG. 13. An actuator lever 264 may extend outside ofthe outer shell 16 chassis portion 14 and be operatively coupled to theanchor deployer carrier 258 in order to translate the anchor deployercarrier 258 in a distal direction upon actuation translation. Such axialtranslation of the anchor deployer carrier 258 from a starting positionwherein the anchors 62 of the anchor deployers 52 are disposedsubstantially within a nominal outer surface contour 266 of the elongatehousing 22 will axially translate each of the deployer rods 56 andassociated anchors 62 in a distal and radially outward direction fromthe elongate housing 22 upon actuation translation as shown in FIG. 12.In some cases, the actuator lever may be manually operated such thatmanually applied compression imposed upon the actuator lever 264 isconverted to axial translation of the anchor deployer carrier 258 in adistal direction. A return spring 268 that is operatively coupledbetween the actuator lever 264 and the chassis portion 14 may beconfigured to resist manually imposed actuation translation of theactuator lever 264 and/or anchor deployer carrier 258 and return theactuator lever 264 and anchor deployment carrier 258 from a displacedposition to a starting position thereof.

Although the anchor deployer actuator 256 discussed above uses manualcompression of the actuator lever 264 to provide the distally directedforce on the deployer rods 56 through the anchor deployer carrier 258,any number of other suitable devices and methods may be used to providethe distally directed force to deploy the anchor deployers 52. In somecases, a compressed spring such as deployment spring 275 included in ananchor deployer actuator 256′ may be used to provide the distallydirected force used to deploy the anchor deployers 52 as shown in FIG.12A. For the deployer actuator embodiment 256′ shown in FIG. 12A, theanchor deployer carrier 258′ may be operatively coupled to thedeployment spring 275 and the proximal section 262 of each of thedeployer rods 56. The actuator lever 264′ is configured to beoperatively coupled to the anchor deployer carrier 258′ so as tomaintain the deployment spring 275 in a compressed state until theoperator is ready to deploy the anchor deployers 52. Once depressed orotherwise actuated, the actuator lever 264′ releases the anchor deployercarrier 258′ such that the deployment spring 275 is released from itsaxially compressed state and the compressed spring force of thedeployment spring 275 then provides the distally directed axial forceonto the deployer rods 56 thereby advancing the anchor deployers 52 in adistal and radially outward direction from the distal section 34 of theelongate housing 22 as discussed above with regard to other embodimentsincluded herein.

Referring to FIGS. 19-21, in some cases, a distal section 45 of each ofthe anchor deployer lumens 42 may be configured to provide an outwardangular deflection of the anchor deployer 52 when the anchor deployer 52is translating distally and extending outwardly from the distal port 44of the anchor deployer lumen 42 or otherwise disposed within andextending from the distal port 44. In some cases, the distal section 45of each of the anchor deployer lumens 42 may include a curved contour270 with respect to a longitudinal axis 272 of a nominal anchor deployerlumen section 274 disposed proximal to the distal section 45 of theanchor deployer lumen 42. The curved contour 270 may be configured toprovide outward angular deflection of the anchor deployer 52 when theanchor deployer 52 is translating distally and extending outwardly fromthe distal port 44 of the anchor deployer lumen 42 as noted above. Insome cases, such a curved contour 270 may form a helical contour withrespect to the distal section 34 of the elongate housing 22.

With regard to quantifying the outward angular deflection of the anchordeployer 52, a discharge axis 276 is the axis defined by a longitudinalaxis of that portion of the deployment rod 56 that is extending from thedistal port 44 of the anchor deployer lumen 42. In some cases, thedistal section 45 of each of the anchor deployer lumens 42 may beconfigured to provide outward angular deflection of the anchor deployer52 having a discharge axis 276 that forms an angle 278 of about 15degrees to about 35 degrees with respect to the longitudinal axis 272 ofthe nominal anchor deployer lumen section 274 disposed proximal to thedistal section 45 of the anchor deployer lumen 42 and/or thelongitudinal axis 244 of the elongate housing 22. For some embodiments,the curved contour 270 of the distal section 45 of each of the anchordeployer lumens 42 may be configured to produce such range of dischargeaxes 276 and associated angles 278 as noted above. For some embodiments,the distal section 45 of each of the anchor deployer lumens 42 may beconfigured to provide an outward angular deflection of the anchordeployer 52 without the use of a curved contour. For example, anabutment, deflection block or other suitable structure (not shown) thatis configured to deflect the anchor deployer 52 may be disposed in thedistal section 45 of anchor deployer lumen 42 that has an otherwisestraight shape without a curved contour.

In addition, the distal section 45 of each of the anchor deployer lumens42 may have a recessed pocket 282 with an inside surface contour 284which is configured to accept an outer surface contour of a respectiveanchor 62 disposed therein with a close fit therebetween. In such cases,a close fit between the inside surface contour 284 of the recessedpocket 282 and outer surface contour of the respective anchors 62 mayinclude a snap fit or a close slip fit wherein the anchors 62 are heldin place in the respective recessed pockets 282 by a lateral forcegenerated by the distal end 58 of the deployer rod 56 that isresiliently bent into a deflected configuration by the curved contourand curvature thereof. This snap fit or close fit may be configured tohold the anchors 62 in place until the anchor deployers 52 are deployedby the anchor deployer actuator 256.

Referring to FIG. 20, the distal section 34 of the elongate housing 22is shown disposed above and adjacent the tissue layer 64 with alongitudinal axis 244 of the elongate housing 22 being aligned with acenter of the passage 216 in the tissue layer and access hole 124 of theblood vessel 128. In some cases, for such an arrangement, thelongitudinal axis 192 of the elongate shaft 82 of the inner catheterassembly 78 (inner catheter assembly 78 not shown in FIG. 20 forpurposes of clarity of illustration) may also be so aligned. Thedeployed anchor deployers 52 shown in FIG. 20 illustrate an asymmetricdeployment pattern that may be useful in certain circumstances.

For such embodiments, a deployment pattern for the anchors 62 of theplurality of anchor deployers 52 may be an asymmetric deploymentpattern. In some cases, for such an asymmetric deployment pattern, theanchor puncture sites may be disposed in the tissue layer 64 on thecorners of a common square or rectangular pattern 243 (or any othersuitable pattern) at the plane of the tissue layer 64. However, the axisof symmetry 245 of such a deployment pattern 243 may be effectivelyshifted laterally, or in any other suitable direction, such that thepuncture sites in the tissue layer 64 for the anchor deployers 52 on oneside of the elongate housing 22 are disposed further from thelongitudinal axis 244 of the elongate housing 22, longitudinal axis 192of the elongate shaft 82 and/or center of the passage 216 than thepuncture sites of the anchor deployers on the other side of the elongatehousing 22 as shown in FIGS. 20 and 20A. FIG. 20A in particular showsschematically how the axis of symmetry 245 of the rectangular deploymentpattern 243 is laterally shifted to the right from the longitudinal axes192, 244 of the elongate shaft 82 and elongated housing 22 indicated bythe distance shown between the axis of symmetry 245 and axes 192, 244.The desired amount or distance of this lateral shift (or shift in anyother direction) may depend on a variety of factors, including certainclinical factors and morphologies. In some cases, the distance of theshift may be equal to or greater than one half a transverse widthmeasurement of the target blood vessel, such as the artery 128. Thedistance of the shift may also be up to a distance of separation of thelongitudinal axis 406 of the target blood vessel 128 and a longitudinalaxis of an adjacent blood vessel such as the vein 130 as shown in FIG.20. For some embodiments, the distance of the shift of the deploymentpattern 243 from the axes 192 or 244 may about 3 mm to about 15 mm, morespecifically, about 5 mm to about 10 mm. Such an asymmetric deploymentpattern may include any other desired deployment pattern 243, other thanpuncture sites at the corners of a square or rectangular pattern, thatyields a desired clinical result.

In some cases, the asymmetric deployment pattern 243 of the anchordeployers 52 may be wider on a side of the target blood vessel 128 thatincludes another vascular structure that is to be avoided and narroweron the side of the target blood vessel 128 that does not include such astructure. For example, if the target vessel 128 is a femoral artery,the deployment pattern may be wider on the side of the elongate housing22 that corresponds to the position of the associated vein 130 (which isto be avoided by the anchor deployers) and narrower on the side of theelongate housing opposite the associated vein 130 as shown in FIG. 20.

For some embodiments, in order to produce an asymmetric deploymentpattern 243 as discussed above, the curved contour 270 of the distalsection 45 of a first anchor deployer lumen 42 of the actuator assembly12 may include a discharge axis 276 forming a first angle 278 withrespect to the longitudinal axis 272 of the nominal anchor deployerlumen section 274 disposed proximal of the distal section 45 of theanchor deployer lumen 42. In addition, the curved contour 270′ of thedistal section 45′ of a second anchor deployer lumen 42′ (not shown) ofthe same actuator assembly 12 may include a discharge axis 276′ forminga second angle 278′ with respect to the longitudinal axis 272′ of thenominal anchor deployer lumen section 274′ (not shown) disposed proximalof the distal section 45′ of the second anchor deployer lumen 42′, thesecond angle 278′ being different from the first angle 278 as shown inasymmetric deployment pattern of FIG. 20. Such an arrangement whereinthe axial positions with regard to the elongate housing 22 of therespective distal ports 44, 44′ is the same but the discharge axis 276of the distal ports 44, 44′ varies may be used to produce an asymmetricdeployment pattern as shown.

However, the overall configuration of the anchor deployer lumens 42 andrespective distal ports 44 may be chosen to produce the same or anyother desired deployment pattern, symmetric or asymmetric, in otherways. For example, to achieve the same or similar asymmetric deploymentpattern as that shown in FIGS. 20 and 20A, the angle 278 of thedischarge axis 276 of each of the deployer lumens 42 may be the same.However, the axial position of the distal ports 44 on one side (the sideof the vein 130) may be disposed proximally farther from the distal end28 of the elongate housing 22 than the distal ports 44 on the sideopposite the vein 130. That is to say, that the axial position anddischarge axis 276 of each of the anchor deployer lumens may beconfigured in any suitable manner in order to produce a desireddeployment pattern and desired offset from the longitudinal axis 244 ofthe elongate housing 22 and/or longitudinal axis 192 of the elongateshaft 82.

Referring to FIGS. 29 and 30, any number of configurations of anchorembodiments 62 and deployment rod embodiments 56 may be used for theplurality of anchor deployers 52 that provide a useful and reliableanchoring function. In some cases, embodiments of the anchor 62 mayinclude a sharpened distal tip 286 like a trocar tip which is configuredto penetrate tissue 64 in a distal direction as shown in FIG. 29. Suchanchor embodiments 62 may also include tabs 288 at the proximal end 290of the anchor 62 that can be raised or otherwise deflected in an outwardradial direction. The tabs 288 may be configured to create a featurethat can engage tissue 64 and serve to aid separation of the anchor 62from the distal end 58 of the deployment rod 56 during retraction of thedeployment rod 56 from the anchor embodiments 62 by resisting retrogradetranslation of the anchor 62 once it is deployed into tissue. Suchanchor embodiments 62 including proximal tubular portions thereof may bereleasably disposed onto the distal end 58 of a respective deploymentrod 56. For such embodiments, the distal tip 58 of the deployment rod 56may have any suitable shape such as flat, blunt or the like and does notneed to be sharpened as the distal tip 58 does not interact directlywith tissue 64 upon distal extension and actuation. Each anchorembodiment 62 may further be secured to the distal end 68 of thefilament 66, the filament being used to apply a radially inward tensionforce to each of the anchors 62 once they have been deployed into targettissue of the tissue layer 64. The anchors 62 having sharpened distaltips 286 may be made from any suitable rigid high strength material thatis configured for tissue penetration and anchoring. In some cases, suchanchor embodiments 62 may be made from metals such as stainless steel,nickel titanium alloy or the like which may, in some cases, benon-bioabsorbable. In some cases, such anchors may also includebio-absorbable materials.

In other embodiments, each anchor deployer 52 of the plurality of anchordeployers 52 may include a deployment rod 56′ having a sharpened tissuepenetrating tip 294 disposed on the distal end 58′ of the deployment rod56′ as shown in FIG. 30. For such embodiments, the respective anchor 62′may be removably secured to the distal end 58′ of the deployment rod 56′and have a tubular configuration and without a sharpened distal tip 286.Such deployment rod embodiments 62′ may further include an anchorreceiving surface 296 disposed proximally of the sharpened tissuepenetrating tip 294 which has an outer surface contour 298 which isconfigured to mate with an inside surface contour of an inner lumen 302of the tubular configuration of the anchor embodiment 62′. In addition,the deployment rod embodiment 56′ may further include a shoulder 304having a stop surface 306 which is distally facing and disposed at aproximal end 308 of the anchor receiving surface 296. In such instances,the stop surface 306 may extend radially outward from the anchorreceiving surface 296 and function to fix the axial position of theanchor 62′ on the anchor receiving surface 296 during tissuepenetration.

Such anchor embodiments 62′ may further include filament attachmentfeature or loop 312 disposed on an outer surface 314 of the anchor 62′or in any other suitable location which has a filament hole 316 or othersuitable feature which is configured to be secured to the distal end 68of a filament 66 such as a suture. In some cases, the filament hole 316may be secured to the distal end 68 of the filament 66 by crushing orcrimping the loop material of the filament attachment feature 312 ontothe distal section 68 of the filament 66. Such a filament attachmentfeature 312 may also be used on any other anchor embodiments 62discussed herein including those anchor embodiments having sharpeneddistal tips 286.

The anchor embodiments 62′ without a sharpened distal tip 286 may bemade from any suitable rigid high strength material that is configuredfor anchoring. In some cases, such anchor embodiments 62′ may be madefrom metals such as stainless steel, nickel titanium alloy or the likewhich may, in some cases, be non-bioabsorbable. In some cases, suchanchor embodiments 62′ may also include bio-absorbable materials.

Some anchor deployer embodiments 52 may include anchors 62″ which areeach secured to an elongate and flexible filament 66 and which may beconfigured to be distally ejected from a distal end 322 of an innerlumen 326 of hollow deployment needle 324. For such embodiments, thehollow deployment needle 324 may have a sharpened distal tip 328 and beconfigured to penetrate tissue 64 upon deployment such that the anchor62″ disposed therein does not require any tissue penetratingcharacteristics. As such, the anchor embodiments 62″ may have a varietyof configurations due to serving only a single purpose, i.e., anchoringonce deployed into target tissue 64 without the need to be sharpened fortissue penetration or inclusive of features such as tabs 288 to resistproximal withdrawal in tissue 64 to facilitate removal from deploymentrods 56 as discussed above. The hollow deployment needles 324 may takethe place of the deployment rods 56 and have their proximal ends securedto a carrier such as the anchor deployer carrier 258 and function in thesame or similar manner as the anchor deployer actuator 256 discussedherein.

These anchor embodiments 62″ may be deployed from the distal ends 322 ofthe inner lumens 326 of the hollow deployment needle 324 by distaltranslation of pusher rods 332 disposed within the inner lumen 326 ofthe hollow deployment needles 324 proximal of the anchor 62″. The pusherrod embodiments 332 may have a flexible configuration and be disposedwithin and along the inner lumens 326 of the hollow deployment needles324. The pusher rods 332 may be distally advanced and deployed so as todeploy the anchors 62″ from the distal ends 322 by any suitable meansincluding an actuator (not shown) that may be similar to or the same asthe anchor deployer actuator embodiments 256 shown and discussed herein.For such embodiments, proximal ends or sections of the pusher rods 332may be operatively coupled to a carrier, such as the anchor deployercarrier 258 and associated structures. Some hollow deployment needleembodiments 324 may include slotted tubes of resilient high strengthmaterial such as slotted hypo tubes made from stainless steel, nitinolor the like including transverse slots 325 disposed through a wall ofthe deployment needle 324. The anchor embodiments 62″ may include rigidor compliant bio-compatible materials such as stainless steel, nitinol,PTFE pledgets, bio-absorbable polymers, and non-bioabsorbable polymers.In some instances, the anchors 62″ may be configured to expand afterdeployment from the distal ends 322 of the inner lumens 326 of thehollow deployment needles 324.

The actuator assembly 12 of the vascular closure assembly 10 may alsoinclude a filament tensioning mechanism 336 which is configured tocontrollably apply axial tension to the filaments 66 of the respectiveplurality of anchor deployers 52 in order to pull the filaments 66 backinto the elongate housing 22 and draw the anchors 62 which have beendeployed into the tissue layer 64 closer together. In some cases, thefilament tensioning mechanism 336 may include a filament terminal 338which is secured to proximal ends of the filaments 66 of the pluralityof anchor deployers 52 and a tensioning spring 342 which is operativelysecured to the filament terminal 338. The filament terminal 338 may betranslatable from a first position wherein there is no tension forceapplied to the filaments 66 by the filament terminal 338 and a secondposition wherein the tension force is applied to the filaments 66 by thetensioning spring 342 through the filament terminal 338.

For some embodiments, the filament tensioning mechanism 336 may bedisposed on the chassis portion 14 and further include a threaded rod344 which is configured to be rotatable about a longitudinal axis 346thereof but axially fixed with respect to the chassis portion 14. Thefilament tensioning mechanism 336 may also include a tension controlblock 348 that has a threaded bore 352 which is operatively coupled tothe threaded rod 344. For such embodiments, the tension control block348 may be rotationally fixed but axially translatable with respect tothe chassis portion 14 such that rotation of the threaded rod 344relative to the chassis portion 14 and tension control block 348 axiallytranslates the tension control block 348 with respect to the chassisportion 14. In addition, a tension transfer clip 354 may be used toreleasably couple the filament terminal 338 to the tension control block348 in an orientation that opposes a tension force of the tensioningspring 342 in order to controllably apply the tension force of thetensioning spring 342 to the filaments 66 through the filament terminal338. The filament tensioning mechanism 336 may also have a knob 356secured to an outer end 358 of the threaded rod 344 in order to providea comfortable grip for a user applying rotational force to the threadedrod 344.

For this configuration, at the beginning of a procedure prior toactivation of the knob 356, the tension control block 348 is disposed inan upper axial position along the threaded rod 344 wherein the entiretension force of the tensioning spring 342 is being transferred to andopposed by the tension control block 348 through the tension transferclip 354 with no tension being applied to the filaments 66. As the knob356 is rotated and the tension control block 348 translates downward,the opposition to the tension force generated by the tensioning spring342 is decreased with respect to the tension control block 348 as anyslack in the filaments 66 is removed and that tension force begins to beapplied to the filaments 66. As the knob 356 is further rotated and thetension control block 348 translates further downward, more and more ofthe tension force is transferred from the tension control block 348 andonto the filaments 66 through the filament terminal 338. Eventually, allof the tension force from the tensioning spring 342 is transferred tothe filaments 66 and the tension transfer clip 354 completely decouplesfrom the tension control block 348 as shown in FIG. 57 and discussedbelow. Such a configuration is very useful for controllably applying aconsistent and repeatable tension force to the filaments 66,particularly where the tensioning spring 342 is a constant force typespring that does not vary significantly in tensioning force as afunction of small displacements of the end of the tensioning spring 342,as is the embodiment shown.

Once the anchors 62 have been deployed by the anchor deployers 52 andthe filaments 66 retracted in order to reduce or close the passage inthe tissue layer 64, it may be useful to fix the filaments 66 in theretracted configuration. Some embodiments of the actuator assembly 12 ofthe vascular closure assembly 10 may include the filament lock mechanism72 as shown in FIGS. 3, 21-23 and 59-60. Embodiments of the filamentlock mechanism 72 may include the filament tube 37 which has a distalsection 40 which is slidably disposed in a close fitting bore 362 at adistal section 34 of the elongate housing 22. The filament tube 37 mayalso have a distal end 364 which extends distally beyond a distalshoulder surface 366 of the close fitting bore 362. The filament tube 37may be slidably disposed in an axial direction relative to the elongatehousing 22 and distal shoulder surface 366 and include the innerfilament lumen 36 disposed about the filaments 66. The filament tube 37may further include a proximal section 368 as shown in FIG. 22.

The filament lock mechanism 72 may also include the filament lock 76 (ora plurality of filament locks 76) which has an inner lumen 370 which isdisposed about the distal end 364 of the filament tube 37 in an axialposition that is distal of the distal shoulder surface 366 of the closefitting bore 362. Embodiments of the filament lock 76 may be configuredto be self-contracting from an expanded state to a relaxed state andconfigured to clamp onto the filaments 66 disposed in the filament lumen36 of the filament tube 37 once the outward radial support producing theexpanded state of the filament tube 37 is removed. In some embodiments,a filament guide 372 may also be disposed on the distal end 364 of thefilament tube 37 in order to provide a smooth radiused transition fortensioned filaments 66 being routed into the distal port 38 of thefilament lumen 36 of the filament tube 37 and to prevent abrasion orother damage to the filaments 66 at this position where they are beingsubjected to a right angle bend at a small radius in some cases. Afilament lock bushing 373 may also be disposed on the filament tube 37proximal of the filament lock 76 and distal of the distal shouldersurface 366. The filament lock bushing 373 may have an inner lumen thatis a close but slidably disposed fit with the outside surface of thefilament tube 37 similar to that of the close fitting bore 362.

The filament lock mechanism 72 may further include a filament tubeactuator 374 which is operatively coupled to the proximal section 368 ofthe filament tube 37 and which is configured to axially retract thefilament tube 37 in a proximal direction relative to the distal shouldersurface 366 upon activation so as to push the filament lock 76 off ofthe distal end 364 of the filament tube 37 and allow the filament lock76 to clamp onto the filaments 66 disposed in the filament lumen 36 ofthe filament tube 37. Some embodiments of the filament lock mechanism 72may have a plurality of filaments locks 76 disposed axially adjacenteach other on the distal end 364 of the filament tube 37 in an axialposition distal of the distal shoulder surface 366 of the close fittingbore 362. In some cases, the filament tube 37 may have a rigid tubularstructure comprised of a high strength material. In some cases, the highstrength material of the filament tube 37 may include stainless steel.

Some embodiments of the filament lock 76 may include a “trailing lock”type configuration with a tubular structure including a main bodyportion 378 and also including a plurality of fingers 382 extendingproximally from the main body portion 378 as shown in FIGS. 21-24. Insome cases, the fingers 382 may be of sufficient axial length andelastically biased towards a center longitudinal axis 384 of the mainbody portion 378 such that respective distal ends 386 of the fingers 382are configured to be self-contracting in an inward radially orienteddirection. The fingers 382 may be so self-contracting from an expandedstate to a relaxed state so as to clamp onto the filaments 66 disposedwithin the inner lumen 370 of the filament lock 76 when the fingers 382are in the relaxed state. In the contracted state, an inside surface ofthe distal ends 386 of the fingers 382 may form a residual lumen 383 inthe absence of any filaments disposed therein. In addition, these fingerembodiments 382 may be elastically spread in an outward radial directionto a relative transverse separation to generate the expanded state whichmay be sufficient to fit onto an outer surface of the distal end 364 ofthe filament tube embodiments 37. For the filament lock embodiment 76shown, the fingers 382 have a generally triangular shape with a baseportion disposed opposite the distal end 386 and adjacent the proximalend of the main body portion 378 that is wider than the respectivedistal end 386 thereof.

For some embodiments, an axial length of the main body portion 378 maybe the same as or similar to an axial length of the fingers 382. Forsuch embodiments, an overall axial length of the filament lockembodiments 76 may be about 0.06 inches to about 0.1 inches, morespecifically, about 0.075 inches to about 0.085 inches. Such filamentlock embodiments may have an inner lumen 370 with an inside diameter ofabout 0.04 inches to about 0.06 inches, more specifically, about 0.045inches to about 0.055 inches. The same embodiment, may, in some cases,have wall thickness of the tubular structure of the main body portion378 and fingers 382 of about 0.013 inches to about 0.023 inches, morespecifically, about 0.016 inches to about 0.020 inches. For someembodiments, a ratio of an axial length of the fingers 382 to the insidediameter of the inner lumen 370 may be about 0.6 to about 1.5. In somecases, the residual lumen formed by the distal ends 386 of the fingers382 in a relaxed state in the absence of any filaments 66 disposedtherein may have a transverse dimension of about 0.010 inches to about0.015 inches and a ratio of such a residual lumen to the insidetransverse dimension of the inner lumen 370 may be about 0.1 to about0.7. For some embodiments, a ratio of a wall thickness of the tubularstructure of the main body portion 378 relative to an outer diameter ofthe tubular structure of the main body portion 378 may be about 0.05 toabout 0.25. For the filament lock embodiment 76 shown, the fingers 382are substantially evenly spaced about a circumference of the main bodyportion 378, however, any suitable circumferential spacing may be used.In some instances, embodiments of the filament lock 76 may have about 3fingers 382 to about 10 fingers 382, more specifically, about 4 fingers382 to about 6 fingers 382. Some embodiments of such filament locks 76may be made from or include highly resilient materials includingsuperelastic materials. Such superelastic materials may includesuperelastic polymers or superelastic metal alloys such as nickeltitanium alloys or the like.

Some embodiments of the filament lock 76′ may include a coiled springfilament 376 wherein the inner lumen 370 of the filament lock 76′ issized to clamp onto the filaments 66 disposed therein when in acontracted state as shown in FIGS. 25-28. In some such embodiments,coiled spring filament 376 may have a non-round transverse cross sectionprofile. For example, in some cases, the transverse cross sectionprofile of the coiled spring filament may have rectangular or diamondshaped profile so that the sharp edges of such profiles may be used tobite into the outside surface of the filaments 66 and provide aneffective lock therebetween. In some instances, such an arrangement mayprovide a more secure lock between the filaments than might be providedby a coiled spring filament 376 having a round or substantially roundtransverse cross section profile. For such embodiments, the inner lumen370 may be elastically enlarged to a transverse dimension sufficient tofit onto an outer surface of the distal end 364 of the filament tube 37as shown in FIG. 28.

Once the retracted filaments 66 of the vascular closure assembly 10 havebeen locked in place relative to each other, it may be useful to cut thefilaments 66 at a position proximal of the filament lock 76. As such,some embodiments of the actuator assembly 12 further may include afilament cutter 390 disposed in operative arrangement with the filaments66 of the respective plurality of anchor deployers 52 as shown in FIGS.12, 17, and 18. In some cases, the filament embodiments 66 may includesutures and the filament cutter 390 may include a suture cutterincluding a sharpened blade 392 that is angled towards the sutures 66and disposed in a slide 394 that is configured to translate transverselyin a bore 396 relative to the sutures 66. For such embodiments, theblade 392 may approximate the sutures 66 during transverse translationof the blade 392 so as to contact the sutures 66 with a sharpened edge398 of the blade 392 and cut through the sutures 66 prior to the end ofa corresponding transverse actuation stroke. In some cases, the suturecutter 390 may be disposed on the chassis portion 14 of the actuatorassembly 12.

In use, embodiments of the vascular closure assembly 10 may be used toreduce the size of or eliminate the passage 216 in the tissue layer 64disposed above and adjacent the access hole 124 in the blood vessel 128so as to provide hemostasis with regard to the access hole 124 in theblood vessel 128 after a minimally invasive vascular procedure or thelike. Such devices and procedures discussed herein for providing suchhemostasis may do so indirectly without directly closing the access hole124 in the blood vessel 128 or suturing or otherwise penetrating thewall portion 126 of the blood vessel 128 during the hemostasis process.This may be particularly useful in circumstances where the wall portion126 of the blood vessel 128 is diseased or otherwise compromised such asby the presence of calcified plaque as well as many other circumstances.

Some embodiments of a method for vascular closure may include distallyadvancing the vascular closure assembly 10 over an exposed proximalportion 402 of the guidewire 117 which has a distal section 404 thereofdisposed through the access hole 124 in a blood vessel 128 of thepatient and through the passage 216 in the tissue layer 64 disposedabove and adjacent the access hole 124 as shown in FIG. 49. Theguidewire 117 is also disposed through the patient's skin layer 125 andthe tissue disposed between the patient's skin 125 and the tissue layer64. The method may further include distally advancing the vascularclosure assembly 10 over the guidewire 117 while the inner catheterassembly 78 of the vascular closure assembly 10 is disposed within theinner lumen 32 of the elongate housing 22 of the actuator assembly 12 ofthe vascular closure assembly 10.

In some cases, the vascular closure assembly 10 may be so advanced withthe self-inflating balloon 94 of the inner catheter assembly 78extending distally beyond the distal end 28 of the elongate housing 22and with the inner catheter assembly 78 releasably secured to theactuator assembly 12 by the inner catheter assembly position lock 212 toprevent relative axial displacement therebetween. In addition, advancingthe vascular closure assembly 10 over the guidewire 117 may include, insome cases, distally advancing the guidewire lumen 114 of the elongateshaft 82 of the inner catheter assembly 78 of the vascular closureassembly 10 over the guidewire 117.

For some embodiments, the vascular closure assembly 10 may continue tobe advanced until blood is observed being emitted from the proximal port122 of the blood return lumen 118 of the inner catheter assembly 78 asshown in FIG. 50. The emission of blood 123 from the proximal port 122indicates that the distal port 120 of the blood return lumen 118 isdisposed within the inner lumen 150 of the patient's blood vessel 128and suitably positioned for deployment of the foot extension 166.Typically, the distal section 34 of the elongate housing 22 is disposedat or below the patient's outer skin layer 125 at this stage as well.

The method thus includes deploying the foot extension 166 from theelongate shaft 82 of the inner catheter assembly 78. In some instances,the foot extension 166 is deployed from a position within the interiorvolume 98 of the self-inflating balloon 94 as shown in FIGS. 39 and 50.The foot extension 166 in this case is disposed along the elongate shaft82 within the interior volume 98 of the self-inflating balloon 94 suchthat as the foot extension 166 extends radially outward from theelongate shaft 82 it may also push a portion of the wall 96 of theself-inflating balloon 94 radially outward, however, the wall 96 of theself-inflating balloon 94 may be configured to be thin and flexibleenough to conform to the outer contour of the foot extension 166 and notinterfere with the function of the foot extension 166. As discussedabove, in some cases the foot extension 166 may be disposed axiallycoextensive with the self-inflating balloon 94, but not within theinterior volume 98. For such embodiments, the foot extension 166 may bedeployed from the position outside the interior volume 98.

Once the foot extension 166 has been deployed, the vascular closureassembly 10 may be proximally retracted until contact or othermechanical interaction or abutment between the foot extension 166 and aninner surface 152 of the inner lumen 150 of the blood vessel 128 of thepatient adjacent the access hole 124 prevents further proximaldisplacement of the inner catheter assembly 78 as shown in FIG. 50A. Inthis configuration, generally an axial portion of the self-inflatingballoon 94 overlaps the access hole 124. In addition, it should be notedthat in this configuration with the foot extension 166 deployed andpreventing further proximal retraction of the vascular closure assembly10 (or inner catheter assembly 78 only if the inner catheter assembly 78is optionally not releasably secured to the actuator assembly 12) therewill be a layer of the wall 96 of the self-inflating balloon 94 disposedbetween the outer surface of the foot extension 166 and the innersurface 152 of the blood vessel 128 even though the surfaces aremechanically opposed to each other.

Once the self-inflating balloon 94 and foot extension 166 disposedtherein are axially secured in place, the balloon inflation valve 112 ofthe inner catheter assembly 78 as shown in FIGS. 36 and 37 may be openedusing the balloon inflation lever 148 allowing pressurized blood fromwithin the interior volume 150 of the patient's blood vessel 128 to flowthrough the balloon inflation lumen 102 of the inner catheter assembly78 and into an interior volume 98 of the self-inflating balloon 94. Theself-inflating balloon 94 may continue to be allowed to inflate untilcontact and hemostasis is established between an outer surface 154 ofthe self-inflating balloon 94 and the perimeter surface 156 of theaccess hole 124 in the blood vessel 128 as shown in FIG. 51.

The inner catheter assembly 78 may then be released from the actuatorassembly 12 by releasing the inner catheter assembly position lock 212to allow the inner catheter assembly 78 to axially translate relative tothe actuator assembly 12. The actuator assembly 12 is then distallyadvanced over the inner catheter assembly 78 while holding the innercatheter assembly 78 in a fixed axial position relative to the accesshole 124 in the blood vessel 128 until the distal end 28 of an elongatehousing 22 of the actuator assembly 12 is disposed adjacent the passage216 in the tissue layer 64 as shown in FIG. 52. In some cases, theactuator assembly 12 may be distally advanced over the inner catheterassembly 78 until the proximal index 226 of the actuator assembly 12 isaligned with the insertion alignment mark 224 disposed on the innercatheter assembly 78.

This technique may be useful for a variety of patients having a varietyof tissue morphologies in the area of the passage 216 in the tissuelayer 64 and the access hole 124. Generally speaking, the distancebetween the tissue layer 64 (such as a fascia layer, for example) andthe blood vessel wall 126 (such as a blood vessel wall 126 of a femoralartery, for example) is fairly consistent patient to patient, eventhough the distance between an outer surface of the patient's skin andthe fascia layer 64 may vary greatly patient to patient.

In some cases, once in position, the inner catheter assembly 78 may thenbe releasably secured to the actuator assembly 12 by activating theinner catheter assembly position lock 212. In some instances, it mayalso be useful at this point to orient the longitudinal axis 244 of theelongate housing 22 relative to the longitudinal axis 406 of the bloodvessel 128 of the patient as indicated by arrows 407 as shown in FIG.52. Orienting the longitudinal axis 244 of the elongate housing 22relative to the longitudinal axis 406 of the blood vessel 128 of thepatient may include forming an angle of about 50 degrees to about 80between the longitudinal axis 244 of the elongate housing 22 and thelongitudinal axis 406 of the blood vessel 128. Orienting thelongitudinal axis 244 of the elongate housing 22 relative to thelongitudinal axis 406 of the blood vessel 128 of the patient may alsoinclude observing the angular alignment mechanism 232 and adjusting theangle between the longitudinal axis 244 of the elongate housing 22 andthe longitudinal axis 406 of the blood vessel 128 until the ball bearing248 disposed in the conical cavity 236 of the angular alignmentmechanism 232 is centered at the axis of symmetry 238 of the conicalcavity 236. It may also be useful to orient an axis 408 of the handle 46of the actuator assembly 12 with the longitudinal axis 406 of the bloodvessel 128 of the patient at this stage.

The plurality of anchor deployers 52 may now be deployed in a distal andradially outward direction away from a distal section 34 of the elongatehousing 22 of the vascular closure assembly 10 by activating theactuating lever 264 of the anchor deployer actuator 256. For someembodiments, activating the actuating lever 264 may include depressingthe actuator lever 264 which is coupled to the anchor deployer carrier258 which is operatively coupled to the proximal section 262 of each ofthe plurality of deployer rods 56 as shown in FIGS. 53 and 54. For someembodiments, depressing the actuator lever 264 results in rotation ofthe actuator lever 264, which in turn axially translates the anchordeployer carrier 258 and proximal section 262 of the plurality ofdeployer rods 56 in a distal direction. The anchor deployers 52 maydeployed such that the anchors 62 extend distally beyond the distal end28 of the elongate housing 22 and the tissue layer 64 is penetrated orotherwise engaged so as to support axial tension on the filaments 66 inpositions disposed about the passage 216 in the tissue layer 64 withrespective anchors 62 of the plurality of anchor deployers 52 as shownin FIG. 54. In some cases, deploying the plurality of anchor deployers52 in a distal and radially outward direction away from the distalsection 34 of the elongate housing 22 may include deploying theplurality of anchor deployers 52 in an asymmetric pattern about thelongitudinal axis 244 of the elongate housing 22 as shown in FIG. 20 anddiscussed above.

The anchors 62 are secured to the tissue layer 64 in these positionsdisposed about the passage 216 in the tissue layer 64. In some cases,securing the anchors 62 to the tissue layer 64 in the positions disposedabout the passage 216 in the tissue layer 64 may include penetrating thetissue layer 64 with each of the anchors 62 of the respective anchordeployers 52 and detaching each anchor 62 from its respective deploymentrod 56 at a position beneath the tissue layer 64. Although anchorembodiments 62 are shown being deployed, anchor embodiments 62′ or 62″or any other suitable anchor embodiment and associated anchor deployerembodiment 52 may be used for this method. At this stage, the actuatorassembly 12 may also be optionally rotated and angularly oriented untilthe longitudinal axis 244 of the elongate housing 22 is substantiallyperpendicular to the longitudinal axis 406 of the blood vessel 128 afterdeploying the anchor deployers 52 and prior to proximally retractingdeployment rods 56 of the anchor deployers 52. Such a perpendicular orsubstantially perpendicular orientation may be useful in somecircumstances to facilitate a desired engagement of the anchor deployers52 with the tissue layer 64.

The deployment rods 56 of the anchor deployers 52 may then be proximallyretracted into the elongate housing 22 by releasing the spring loadedanchor deployer actuator 256 or by any other suitable means as shown inFIG. 55. The anchors 62 may now be drawn closer together by applyingproximal tension to the filaments 66 secured to each of the anchors 62.The anchors 62 and respective portions of the tissue layer 64 secured toeach of the anchors 62 are thus drawn together closer to each other asthe filaments 66 are tensioned and translated in an inward generallyradial direction thereby reducing the transverse dimension of thepassage 216 in the tissue layer 64 as shown in FIG. 56.

In some instances, applying proximal tension to the filaments 66 securedto each of the anchors 62 may include actuating the filament tensioningmechanism 336 which is configured to controllably apply a tension forceto the filaments 66. For some embodiments, actuating the filamenttensioning mechanism 336 may include controllably translating thefilament terminal 338 which is secured to the filaments 66 and thetensioning spring 342. In addition, for some embodiments, controllablytranslating the filament terminal 338 may include rotating the knob 356secured to the threaded rod 344 which is operatively coupled to thethreaded bore 352 of the tension control block 348 wherein the tensiontransfer clip 354 releasably couples the filament terminal 338 to thetension control block 348 in an orientation that opposes the tensionforce of the tensioning spring 342. In addition, for such embodiments,rotating the knob 356 may reduce opposition of the tension force appliedby the tension control block 348 in order to controllably apply thetension force of the tensioning spring 342 to the filaments 66. For suchembodiments, the knob 356 may be so rotated until the tension controlblock 348 disengages the filament terminal 338 and all of the tensionforce from the tensioning spring 342 is applied to the filaments 66through the filament terminal 338 as shown in FIG. 57.

The balloon inflation valve 112 of the inner catheter assembly 78 maythen be closed at this stage by deactivating the balloon inflation lever148 thus closing off the balloon inflation lumen 102 which preventsfluid communication between the interior volume 150 of the blood vessel128 and the interior volume 98 of the self-inflating balloon 94. Assuch, inflation pressure from within the interior volume 150 of theblood vessel 128 is excluded from the interior volume 98 of theself-inflating balloon 94 and the interior volume 98 may also be ventedto the ambient atmosphere back through the inflation port 104 andtowards the proximal chassis 92 as shown in FIG. 37 thereby allowing theself-inflating balloon 94 to deflate. The inner catheter assemblyposition lock 212 may then be released and the elongate shaft 82 of theinner catheter assembly 78 and the self-inflating balloon 94 distallyadvanced slightly in order to relieve the mechanical interaction betweenthe inner surface 152 of the blood vessel 128 and the deployed footextension 166. The foot extension 166 may then be retracted back intothe retracted position by deactivating the foot extension actuator 168on the proximal chassis 92.

The inner catheter assembly 78 is then proximally withdrawn within andrelative to the inner lumen 32 of the elongate housing 22 of theactuator assembly 12 until the proximal index 226 of the actuatorassembly 12 is aligned with the retraction alignment mark 228 on theelongate shaft 82 of the inner catheter assembly 78. Such an axialalignment of the inner catheter assembly 78 and actuator assembly 12indicates that the deflated self-inflating balloon 94 and the distal end86 of the elongate shaft 82 have been proximally retracted into theinner lumen 32 of the elongate housing 22 and are no longer interactingwith the access hole 124 or passage 216 in the tissue layer 64. Thisalignment may also indicate that the elongate shaft 82 of the innercatheter assembly 78 has been entirely withdrawn with only the guidewire117 remaining in the passage 216 as shown in FIG. 58.

As the inner catheter assembly 78 is being withdrawn, the deflatedself-inflating balloon 94 may be simultaneously withdrawn from theaccess hole 124 and passage 216 in the tissue layer 64 allowing thetension on the filaments 66 which are secured to the tissue layer 64 tofully close the passage 216 in the tissue layer 64. During this process,it should be noted that once tension force of the tensioning spring 342has been applied to the anchored filaments 66, the tissue layer 64disposed about the self-inflating balloon 94 is being tightened aroundthe outside surface 154 of the self-inflating balloon 94 so as toprovide hemostasis therebetween regardless of whether the self-inflatingballoon 94 is in an inflated state or deflated state. The pressure ofthe tissue layer 64 disposed about the passage 216 which is disposedabout the self-inflating balloon 94 is not so great, however, as toprevent the outside surface 154 of the self-inflating balloon 94 andelongate shaft 82 distal of the self-inflating balloon 94 to axiallyslide through the passage 216 of the tissue layer 64 during proximalwithdrawal of the inner catheter assembly 78.

One or more filament locks 76 may then be deployed onto the filaments 66at the distal end 28 of the elongate housing 22 by activating thefilament lock mechanism 72 while maintaining tension force on thefilaments 66 with the tensioning spring 342. In some cases, activatingthe filament lock mechanism 72 may include depressing the filament tubeactuator 374 which is coupled to a filament tube 37 disposed about thefilaments 66 in the elongate housing 22 thereby proximally retractingthe filament tube 37 as shown by the arrow 375 in FIG. 59. The proximalretraction may be continued until at least one filament lock 76 in anexpanded state is pushed off the distal end 364 of the filament tube 37and onto the filaments 66 as shown in FIG. 60.

For such embodiments, the filament lock 76 may include aself-contracting configuration and the deployment method embodiment mayfurther include allowing the self-contracting filament lock 76 tocontract to a relaxed state over the filaments 66 thereby clamping theat least one filament lock 76 onto an outside surface of the filaments66 and to each other once the outward radial support of the filamenttube 37 is removed from within the filament lock 76. The outward radialsupport of the filament tube 37 against the inside surface of thefilament lock 76 may be removed by proximally retracting the distal end364 of the filament tube 37 past the distal shoulder 366 of the closefitting bore 362 and optional filament lock bushing 373 disposed aboutthe distal end 364 of the filament tube 37. In some cases, a pluralityof filament locks 76 may be deployed by pushing the plurality offilament locks 76 off the distal end 364 of the of the filament tube 37and onto the filaments 66. For example, in some cases, 2, 3, 4, 5 ormore filament locks 76 may be deployed onto the filaments 66 in order tosecure the filaments 66 in a fixed relation to each other and lock themin a tensioned state.

For the filament lock embodiments 76 shown, clamping the at least onefilament lock 76 onto the filaments 66 may include deflecting theplurality of proximally extending fingers 382 of the trailing lockfilament lock embodiments 76 in an inward radial direction and clampingproximal ends 386 of the proximally extending fingers 382 onto thefilaments 66. In some cases, the deployment may include wedgingproximally extending fingers 382 of a distal-most trailing lock filamentlock embodiment 76 into the inner lumen 370 of the proximally adjacentfilament lock 76 during deployment.

The filaments 66 may then optionally be cut at a position which isproximal of the filament lock 76 by actuating the filament cutter 390 ofthe actuator assembly 12. As discussed above, the filament cutter 390and sharpened blade 392 thereof may be disposed in operative arrangementwith the filaments 66. In some cases, the sharpened blade 392 of thetissue cutter 390 may be disposed in the slide 394 and actuating thefilament cutter 390 of the actuator assembly 12 may include translatingthe slide 394 and sharpened blade 392 in the bore 396 relative to thefilaments 66 thereby approximating the filaments 66 during transversetranslation and contacting the filaments 66 with the sharpened edge 398of the blade 392 thereby cutting through the filaments 66. Once thefilaments 66 have been trimmed, the vascular closure assembly 10 may bewithdrawn from the patient and treatment of the puncture site completedas shown in FIG. 61.

Embodiments illustratively described herein suitably may be practiced inthe absence of any element(s) not specifically disclosed herein. Thus,for example, in each instance herein any of the terms “comprising,”“consisting essentially of,” and “consisting of” may be replaced witheither of the other two terms. The terms and expressions which have beenemployed are used as terms of description and not of limitation and useof such terms and expressions do not exclude any equivalents of thefeatures shown and described or portions thereof, and variousmodifications are possible. The term “a” or “an” can refer to one of ora plurality of the elements it modifies (e.g., “a reagent” can mean oneor more reagents) unless it is contextually clear either one of theelements or more than one of the elements is described. Thus, it shouldbe understood that although embodiments have been specifically disclosedby representative embodiments and optional features, modification andvariation of the concepts herein disclosed may be resorted to by thoseskilled in the art, and such modifications and variations are consideredwithin the scope of this disclosure.

With regard to the above detailed description, like reference numeralsused therein refer to like elements that may have the same or similardimensions, materials and configurations. While particular forms ofembodiments have been illustrated and described, it will be apparentthat various modifications can be made without departing from the spiritand scope of the embodiments of the invention. Accordingly, it is notintended that the invention be limited by the forgoing detaileddescription.

What is claimed is:
 1. A vascular closure assembly, comprising: anactuator assembly including: an elongate housing with an inner lumenextending along the elongate housing to the distal end of the elongatehousing, a distal section, and a plurality of anchor deployer lumens,and a plurality of anchor deployers, each anchor deployer being slidablydisposed within a respective deployer lumen of the elongate housing andincluding a distal end which is configured to extend and spread from thedistal section of the elongate housing; and an inner catheter assemblyincluding: an elongate shaft including a proximal end, a distal end, adistal section, an axial length that is sufficient for the distalsection to extend distally beyond the distal end of the elongate housingwhen disposed in the inner lumen thereof, and an outer surface contourwhich is configured to be slidably disposed within the inner lumen ofthe elongate housing, an inflatable balloon disposed on the distalsection of the elongate shaft in an axial position that can extenddistally from the distal end of the elongate housing when the elongateshaft is disposed within the inner lumen of the elongate housing, theinflatable balloon including an interior volume in communication with aballoon inflation lumen, the balloon inflation lumen extending along theelongate shaft from an inflation port which is disposed in fluidcommunication with the interior volume of the inflatable balloon to aninlet port which is disposed on the elongate shaft.
 2. The vascularclosure assembly of claim 1 wherein the inflatable balloon comprises aself-inflating balloon and further comprising a balloon inflation valveconfigured to controllably open and close the balloon inflation lumen.3. The vascular closure assembly of claim 1 further comprising aguidewire lumen extending along the elongate shaft to a distal guidewireport disposed at distal end of the elongate shaft.
 4. The vascularclosure assembly of claim 1 wherein the self-inflating balloon comprisesan outer profile that is configured to self-expand from a compressedstate sized to fit within the inner lumen of the elongate housing to aninflated state which has an outer transverse dimension which is largerthan an outer transverse dimension of the elongate shaft and which isconfigured to plug an access hole in a wall of a blood vessel of apatient.
 5. The vascular closure assembly of claim 4 wherein theself-inflating balloon comprises an elongated outer contour in aninflated state wherein a nominal axial length of the self-inflatingballoon is greater than a transverse dimension of the self-inflatingballoon.
 6. The vascular closure assembly of claim 2 wherein the ballooninflation valve comprises: a plug which has an outer surface contourthat is matched to an inner surface contour of the balloon inflationlumen so as to prevent a flow of fluid therethrough and be slidablydisposed within the balloon inflation lumen, an actuator rod which has adistal end secured to the plug, and a balloon inflation lever which isoperatively coupled to a proximal end of the actuator rod, which isdisposed on a proximal chassis of the inner catheter assembly, and whichis slidable from a first position wherein the plug is disposed distal ofthe inflation port of the balloon inflation lumen thereby blocking fluidcommunication between the inlet portion and inflation port of theballoon inflation lumen, to a second position, the second position beingproximal of the first position and proximal of the inflation port so asto allow fluid communication between the inlet port and inflation portthrough the balloon inflation lumen.
 7. The vascular closure assembly ofclaim 2 wherein the balloon inflation valve comprises a tubular memberwhich is configured to be axially displaced within the balloon inflationlumen of the elongate shaft, and which has a pair of ports coupled influid communication with each other that are axially positioned to alignwith the inlet port and inflation port of the elongate shaft when thetubular member is disposed in the open axial position and positioned tonot be aligned with the inlet port and inflation port when in the closedaxial position.
 8. The vascular closure assembly of claim 1 furthercomprising a foot extension disposed on the elongate shaft within aninterior volume of the self-inflating balloon, the foot extension beingconfigured to extend outwardly from a retracted position wherein thefoot extension is disposed substantially within a nominal outer contourof the elongate shaft to a deployed position wherein an outer end of thefoot extension extends radially outward from the nominal outer contourof the elongate shaft.
 9. The vascular closure assembly of claim 8wherein the elongate shaft further comprises an insertion alignment markthat is visually identifiable by a user and the actuator assemblyfurther comprises a proximal index that is visually identifiable by auser and wherein the foot extension in a deployed state is spaced by apredetermined axial separation from the distal end of the elongatehousing when the insertion alignment mark is axially aligned with theproximal index.
 10. The vascular closure assembly of claim 9 wherein theproximal index and insertion alignment mark are positioned such that thepredetermined axial separation is about 260 mm to about 285 mm.
 11. Thevascular closure assembly of claim 9 wherein the elongate shaft furthercomprises a retraction alignment mark that is visually identifiable by auser and wherein a distal end of the self-inflating balloon is disposedwithin the inner lumen of the elongate housing when the retractionalignment mark is axially aligned with the proximal index.
 12. Avascular closure assembly, comprising: an actuator assembly including: achassis portion having an outer shell with an interior volume disposedwithin the outer shell, an elongate housing with a proximal end securedto a distal end of the chassis portion, a distal end extending away fromthe chassis portion, an inner lumen extending along the elongate housingto the distal end of the elongate housing, a distal section, and aplurality of anchor deployer lumens, each anchor deployer lumenextending axially along the elongate housing and terminating distally ata distal port disposed in the distal section of the elongate housing,and a plurality of anchor deployers, each anchor deployer being slidablydisposed within a respective deployer lumen of the elongate housing andincluding a distal end which is configured to extend and spread from thedistal section of the outer housing, each anchor deployer comprising: adeployment rod which includes an elongate resilient configuration withan axial length greater than a transverse dimension and a distal endthat extends from the distal section of the elongate housing upon distalaxial deployment, and an anchor which is removably secured to the distalend of the deployment rod, and which is configured to resist proximalretraction within tissue; and an inner catheter assembly including: anelongate shaft including a proximal end, a distal end, a distal section,an axial length that is sufficient for the distal section to extenddistally beyond the distal end of the elongate housing when disposed inthe inner lumen thereof, and an outer surface contour which isconfigured to be slidably disposed within the inner lumen of theelongate housing, and an inflatable balloon disposed on the distalsection of the elongate shaft in an axial position that can extenddistally from the distal end of the elongate housing when the elongateshaft is disposed within the inner lumen of the elongate housing, theinflatable balloon including an interior volume in communication with aballoon inflation lumen.
 13. The vascular closure assembly of claim 12wherein the elongate housing further comprises a filament lumen thatextends along the elongate housing and terminates at a distal portdisposed in the distal section of the elongate housing and wherein eachanchor deployer further comprises a filament which is slidably disposedwithin the filament lumen of the elongate housing and which includes adistal end which is secured to the anchor.
 14. The vascular closureassembly of claim 12 further comprising a handle portion having an upperend secured to the chassis portion and a proximal chassis secured to theproximal end of the elongate shaft.
 15. The vascular closure assembly ofclaim 12 wherein the inflatable balloon comprises a self-inflatingballoon and further comprising a balloon inflation valve configured tocontrollably open and close the balloon inflation lumen.
 16. Thevascular closure assembly of claim 12 wherein the actuator assemblyfurther comprising an inner catheter assembly position lock that isconfigured to apply a frictional force to an outside surface of theinner assembly disposed in the inner lumen of the elongate body so as toreleasably secure the inner catheter assembly to the actuator assemblyand temporarily prevent axial displacement of the inner catheterassembly with respect to the actuator assembly.
 17. The vascular closureassembly of claim 12 further comprising an anchor deployer actuatorcomprising: an anchor deployer carrier which is slidably disposed withrespect the chassis portion and which is operatively coupled to aproximal section of each of the plurality of deployer rods, and anactuator lever which extends outside of the chassis portion and which isoperatively coupled to the anchor deployer carrier in order to translatethe anchor deployer carrier in a distal direction upon actuationtranslation and thereby axially translate each or the deployer rods in adistal direction upon actuation translation.
 18. The vascular closureassembly of claim 12 wherein a distal section of each of the anchordeployer lumens is configured to provide an outward angular deflectionof the anchor deployer extending outwardly from the distal port of theanchor deployer lumen.
 19. The vascular closure assembly of claim 18wherein a distal section of each of the anchor deployer lumens comprisesa curved contour with respect to a longitudinal axis of the nominalanchor deployer lumen section disposed proximal to the distal section ofthe anchor deployer lumen to provide outward angular deflection of theanchor deployer extending outwardly from the distal port of the anchordeployer lumen.
 20. The vascular closure assembly of claim 18 whereinthe anchor deployer lumens are configured to produce an asymmetricdeployment pattern of the anchor deployers with respect to alongitudinal axis of the elongate housing.
 21. The vascular closureassembly of claim 20 wherein an axial position and a discharge axis ofeach of the anchor deployer lumens is configured to produce theasymmetric deployment pattern with respect to the longitudinal axis ofthe elongate housing.
 22. The vascular closure assembly of claim 21wherein the curved contour of the distal section of a first anchordeployer lumen comprises a discharge axis forming a first angle withrespect to a longitudinal axis of the nominal anchor deployer lumensection disposed proximal of the distal section of the anchor deployerlumen, and the curved contour of the distal section of a second anchordeployer lumen comprises a discharge axis forming a second angle withrespect to a longitudinal axis of the nominal anchor deployer lumensection disposed proximal of the distal section of the anchor deployerlumen, the second angle being different from the first angle.
 23. Thevascular closure assembly of claim 12 wherein each anchor of theplurality of anchor deployers includes a sharpened distal tip which isconfigured to penetrate tissue in a distal direction.
 24. The vascularclosure assembly of claim 12 wherein the each deployment rod of theplurality of anchor deployers comprises a sharpened tissue penetratingtip disposed on the distal end of the deployment rod and the anchorwhich is removably secured to the distal end of the deployment rod has atubular configuration without a sharpened distal tip.
 25. The vascularclosure assembly of claim 12 further comprising a filament tensioningmechanism configured to controllably apply axial tension to thefilaments of the respective plurality of anchor deployers.
 26. Thevascular closure assembly of claim 12 further comprising a filament lockmechanism disposed at a distal end of the filament lumen, the filamentlock mechanism including a filament lock disposed in operativearrangement with the filaments of the respective plurality of anchordeployers.
 27. The vascular closure assembly of claim 26 wherein thefilament lock mechanism comprises: a filament tube which has a distalsection which is slidably disposed in a close fitting bore at a distalsection of the elongate housing, which has a distal end which extendsdistally beyond a distal shoulder surface of the close fitting bore,which is slidably disposed relative to the elongate housing, which hasan inner lumen disposed about the filaments, and which has a proximalsection, a filament lock which has an inner lumen which is disposedabout the distal end of the filament tube in an axial position that isdistal of the distal shoulder surface of the close fitting bore andwhich is self-contracting from an expanded state to a relaxed state andconfigured to clamp onto the filaments disposed in the inner lumen ofthe filament tube once the outward radial support producing the expandedstate of the filament tube is removed, and a filament tube actuatorwhich is operatively coupled to the proximal section of the filamenttube and which is configured to axially retract the filament tuberelative to the distal shoulder surface upon activation so as to pushthe filament lock off of the distal end of the filament tube and allowthe filament lock to clamp onto the filaments disposed in the innerlumen of the filament tube.
 28. The vascular closure assembly of claim27 wherein the filament lock mechanism comprises a plurality offilaments locks disposed axially adjacent each other on the distal endof the filament tube in an axial position distal of the distal shouldersurface of the close fitting bore.
 29. The vascular closure assembly ofclaim 27 wherein the filament tube comprises a rigid tubular structurecomprised of a high strength material.
 30. The vascular closure assemblyof claim 27 wherein the filament lock comprises a coiled spring filamentwherein the inner lumen is sized to clamp onto the filaments disposedtherein when in a contracted state and the inner lumen may beelastically enlarged to a transverse dimension sufficient to fit onto anouter surface of the distal end of the filament tube.
 31. The vascularclosure assembly of claim 26 wherein the filament lock comprises atubular structure including a main body portion and also including aplurality of fingers extending proximally from the main body portion,the fingers being of sufficient axial length and elastically biasedtowards a center longitudinal axis of the main body portion such thatrespective distal ends of the fingers are configured to beself-contracting from an expanded state to a relaxed state and clamponto the filaments disposed within the inner lumen of the filament lockwhen the fingers are in the relaxed state and the fingers may beelastically spread to a relative transverse separation to the expandedstate sufficient to fit onto an outer surface of the distal end of thefilament tube.
 32. The vascular closure assembly of claim 31 wherein thefilament lock comprises about 3 fingers to about 10 fingers.
 33. Thevascular closure assembly of claim 12 wherein the actuator assemblyfurther comprises a filament cutter disposed in operative arrangementwith the filaments of the respective plurality of anchor deployers. 34.An actuator assembly, comprising: a chassis portion having an outershell with an interior volume disposed within the outer shell; anelongate housing with an axial length greater than a transversedimension thereof, a proximal end secured to a distal end of the chassisportion, a distal end extending away from the chassis portion, an innerlumen extending along the elongate housing to the distal end of theelongate housing, a distal section, a filament lumen that extends alongthe elongate housing and terminates at a distal port disposed in thedistal section of the elongate housing, and a plurality of anchordeployer lumens, each anchor deployer lumen extending axially along theelongate housing and terminating distally at a distal port disposed inthe distal section of the elongate housing; a plurality of anchordeployers, each anchor deployer being slidably disposed within arespective deployer lumen of the elongate housing and including a distalend which is configured to extend and spread from the distal section ofthe outer housing, each anchor deployer comprising: a deployment rodwhich includes an elongate resilient configuration with an axial lengthgreater than a transverse dimension and a distal end that extends fromthe distal section of the elongate housing upon distal axial deployment,an anchor which is removably secured to the distal end of the deploymentrod, and a filament which is slidably disposed within the filament lumenof the elongate housing and which includes a distal end which is securedto the anchor; and a filament lock mechanism disposed at a distal end ofthe filament lumen including a filament lock disposed in operativearrangement with the filaments of the respective plurality of anchordeployers.
 35. The actuator assembly of claim 34 further comprising ananchor deployer actuator comprising: an anchor deployer carrier which isslidably disposed with respect the chassis portion and which isoperatively coupled to a proximal section of each of the plurality ofdeployer rods, and an actuator lever which extends outside of thechassis portion and which is operatively coupled to the anchor deployercarrier in order to translate the anchor deployer carrier in a distaldirection upon actuation translation and thereby axially translate eachor the deployer rods in a distal direction upon actuation translation.36. The actuator assembly of claim 34 wherein a distal section of eachof the anchor deployer lumens comprises a curved contour with respect toa longitudinal axis of the nominal anchor deployer lumen sectiondisposed proximal to the distal section of the anchor deployer lumen toprovide outward angular deflection of the anchor deployer extendingoutwardly from the distal port of the anchor deployer lumen.
 37. Theactuator assembly of claim 36 wherein the curved contour of the distalsection of each of the anchor deployer lumens comprises a discharge axisthat forms an angle of about 15 degrees to about 35 degrees with respectto the longitudinal axis of the nominal anchor deployer lumen sectiondisposed proximal to the distal section of the anchor deployer lumen.38. The actuator assembly of claim 34 wherein the distal end of each ofthe anchor deployer lumens comprises a recessed pocket having an insidesurface which is configured to accept an outer surface contour of arespective anchor disposed therein with a close fit therebetween. 39.The actuator assembly of claim 36 wherein the curved contour of thedistal section of a first anchor deployer lumen comprises a dischargeaxis forming a first angle with respect to a longitudinal axis of thenominal anchor deployer lumen section disposed proximal of the distalsection of the anchor deployer lumen, and the curved contour of thedistal section of a second anchor deployer lumen comprises a dischargeaxis forming a second angle with respect to a longitudinal axis of thenominal anchor deployer lumen section disposed proximal of the distalsection of the anchor deployer lumen, the second angle being differentfrom the first angle.
 40. The actuator assembly of claim 34 wherein eachanchor of the plurality of anchor deployers includes a sharpened distaltip which is configured to penetrate tissue in a distal direction. 41.The actuator assembly of claim 34 wherein the each deployment rod of theplurality of anchor deployers comprises a sharpened tissue penetratingtip disposed on the distal end of the deployment rod and the anchorwhich is removably secured to the distal end of the deployment rod has atubular configuration without a sharpened distal tip.
 42. The actuatorassembly of claim 34 further comprising a filament tensioning mechanismconfigured to controllably apply axial tension to the filaments of therespective plurality of anchor deployers.
 43. The actuator assembly ofclaim 42 wherein the filament tensioning mechanism includes a filamentterminal which is secured to the filaments of the plurality of anchordeployers, a tensioning spring which is operatively secured to thefilament terminal and wherein the filament terminal is translatable froma first position wherein there is no tension force applied to thefilaments by the filament terminal and a second position wherein thetension force is applied to the filaments by the tensioning springthrough the filament terminal.
 44. The actuator assembly of claim 34wherein the filament lock mechanism comprises: a filament tube which hasa distal section which is slidably disposed in a close fitting bore at adistal section of the elongate housing, which has a distal end whichextends distally beyond a distal shoulder surface of the close fittingbore, which is slidably disposed relative to the elongate housing, whichhas an inner lumen disposed about the filaments, and which has aproximal section, a filament lock which has an inner lumen which isdisposed about the distal end of the filament tube in an axial positionthat is distal of the distal shoulder surface of the close fitting boreand which is self-contracting from an expanded state to a relaxed stateand configured to clamp onto the filaments disposed in the inner lumenof the filament tube once the outward radial support producing theexpanded state of the filament tube is removed, and a filament tubeactuator which is operatively coupled to the proximal section of thefilament tube and which is configured to axially retract the filamenttube relative to the distal shoulder surface upon activation so as topush the filament lock off of the distal end of the filament tube andallow the filament lock to clamp onto the filaments disposed in theinner lumen of the filament tube.
 45. The actuator assembly of claim 44wherein the filament lock comprises a coiled spring filament wherein theinner lumen is sized to clamp onto the filaments disposed therein whenin a contracted state and the inner lumen may be elastically enlarged toa transverse dimension sufficient to fit onto an outer surface of thedistal end of the filament tube.
 46. The actuator assembly of claim 44wherein the filament lock comprises a tubular structure including a mainbody portion and also including a plurality of fingers extendingproximally from the main body portion, the fingers being of sufficientaxial length and elastically biased towards a center longitudinal axisof the main body portion such that respective distal ends of the fingersare configured to be self-contracting from an expanded state to arelaxed state and clamp onto the filaments disposed within the innerlumen of the filament lock when the fingers are in the relaxed state andthe fingers may be elastically spread to a relative transverseseparation to the expanded state sufficient to fit onto an outer surfaceof the distal end of the filament tube.
 47. The actuator assembly ofclaim 34 further comprising a filament cutter disposed in operativearrangement with the filaments of the respective plurality of anchordeployers.
 48. The actuator assembly of claim 47 wherein the filamentscomprise sutures and the filament cutter comprises a suture cutterincluding a sharpened blade that is angled towards the sutures anddisposed in a slide that is configured to translate transversely in abore relative to the sutures such that the blade approximates thesutures during transverse translation so as to contact the sutures andcut through them prior to the end of a corresponding transverseactuation stroke.
 49. A catheter assembly including: an elongate shaftincluding a proximal end, a distal end, a distal section; a proximalchassis secured to the proximal end of the elongate shaft; aself-inflating balloon disposed on the distal section of the shaft, theself-inflating balloon including a thin compliant shell material, aninterior volume in communication with a balloon inflation lumen, theballoon inflation lumen extending along the elongate shaft from aninflation port which is disposed in fluid communication with theinterior volume of the self-inflating balloon to an inlet port which isdisposed on the elongate shaft at an axial position which is distal of adistal end of the self-inflating balloon; and a balloon inflation valveconfigured to controllably open and close the balloon inflation lumen.50. The catheter assembly of claim 49 further comprising a footextension disposed on the elongate shaft within an interior volume ofthe self-inflating balloon, the foot extension being configured toextend outwardly from a retracted position wherein the foot is disposedsubstantially within a nominal outer contour of the shaft to an deployedposition wherein an outer end of the foot extension extends radiallyoutward from the nominal outer contour of the shaft substantiallyperpendicular to a longitudinal axis of the elongate shaft.
 51. Thecatheter assembly of claim 50 further comprising a foot extensionactuator configured to change the state of the foot extension betweenthe retracted position and the deployed position.
 52. The catheterassembly of claim 49 further comprising a blood return lumen extendingproximally from the distal end of the elongate shaft to a proximal portof the blood return lumen disposed proximally of the self-inflatingballoon.
 53. The catheter assembly of claim 49 further comprisingguidewire lumen extending along the elongate shaft to a distal guidewireport disposed at distal end of the elongate shaft.
 54. A filament lockcomprising a tubular structure with a main body portion and a pluralityof fingers extending proximally from the main body portion, the fingersbeing of sufficient axial length and elastically biased towards a centerlongitudinal axis of the main body portion such that respective distalends of the fingers are configured to be self-contracting from anexpanded state to a relaxed state and clamp onto filaments disposedwithin the inner lumen of the filament lock when the fingers are in therelaxed state and the fingers may be elastically spread to a relativetransverse separation to the expanded state.
 55. The vascular closureassembly of claim 54 wherein the filament lock comprises about 3 fingersto about 10 fingers.
 56. A method for vascular closure, comprising:distally advancing a vascular closure assembly towards an access hole ina blood vessel and a passage disposed in a tissue layer adjacent theblood vessel while an inner catheter assembly of the vascular closureassembly is disposed within an inner lumen of an elongate housing of thevascular closure assembly, with an inflatable balloon of the innercatheter assembly extending distally beyond the distal end of theelongate housing; inflating the inflatable balloon until contact andhemostasis is established between an outer surface of the inflatableballoon and a perimeter surface of the access hole in the blood vessel;axially translating the actuator assembly over the inner catheterassembly while holding the inner catheter assembly in a fixed axialposition relative to the access hole in the blood vessel until a distalend of an elongate housing of the actuator assembly is disposed adjacentthe passage in the tissue layer; deploying a plurality of anchordeployers in a distal and radially outward direction away from a distalsection of the elongate housing of the vascular closure assembly with ananchor deployer actuator and engaging the tissue layer in positionsdisposed about the passage in the tissue layer with respective anchorsof the plurality of anchor deployers; drawing the anchors closertogether by applying proximal tension to the filaments secured to eachof the anchors so as to draw the anchors and respective portions of thetissue layer secured to each of the anchors together and therebyreducing the transverse dimension of the passage in the tissue layer;and deploying a filament lock onto the filaments at the distal end ofthe elongate housing by activating the filament lock mechanism whilemaintaining tension force on the filaments with the tensioning spring.57. The method of claim 56 wherein distally advancing the vascularclosure assembly comprises distally advancing the vascular closuresystem over a guidewire.
 58. The method of claim 57 wherein distallyadvancing the vascular closure assembly over the guidewire comprisesdistally advancing the vascular closure assembly with an inner catheterassembly releasably secured to the actuator assembly to prevent relativeaxial displacement therebetween.
 59. The method of claim 56 furthercomprising deploying a foot extension from an elongate shaft of theinner catheter assembly from a position within an interior volume of theinflatable balloon such that the foot extension extends radially outwardfrom the elongate shaft.
 60. The method of claim 59 further comprisingproximally retracting the vascular closure assembly until contactbetween the foot extension and an inner surface of the blood vessel ofthe patient adjacent the access hole prevents further proximaldisplacement and an axial length of the inflatable balloon overlaps theaccess hole.
 61. The method of claim 60 wherein the inflatable ballooncomprises a self-inflating balloon and wherein inflating theself-inflating balloon comprises opening a balloon inflation valve ofthe inner catheter assembly and allowing pressurized blood from withinthe patient's blood vessel to flow through a balloon inflation lumen ofthe inner catheter assembly and into an interior volume of theself-inflating balloon.
 62. The method of claim 56 wherein deploying theplurality of anchor deployers in a distal and radially outward directionaway from the distal section of the elongate housing comprises deployingthe plurality of anchor deployers in an asymmetric pattern about thelongitudinal axis of the elongate housing.
 63. The method of claim 56further comprising securing the anchors to the tissue layer in thepositions disposed about the passage in the tissue layer while deployingthe plurality of anchor deployers.
 64. The method of claim 63 whereinsecuring the anchors to the tissue layer in the positions disposed aboutthe passage in the tissue layer comprises penetrating the tissue layerwith each of the anchors of the respective anchor deployers anddetaching each anchor from its respective deployment rod at a positionbeneath the tissue layer.
 65. The method of claim 56 further comprisingrotating the actuator assembly until the longitudinal axis of theelongate housing is substantially perpendicular to the longitudinal axisof the blood vessel after deploying the anchor deployers and prior toproximally retracting deployment rods of the anchor deployers.
 66. Themethod of claim 56 further comprising proximally retracting deploymentrods of the anchor deployers into the elongate housing by releasing theanchor deployer actuator after deploying the plurality of anchordeployers.
 67. The method of claim 56 wherein applying proximal tensionto the filaments secured to each of the anchors comprises actuating afilament tensioning mechanism which is configured to controllably applya tension force to the filaments.
 68. The method of claim 67 whereinactuating the filament tensioning mechanism comprises controllablytranslating a filament terminal which is secured to the filaments and atensioning spring.
 69. The method of claim 56 wherein activating thefilament lock mechanism comprises depressing a filament tube actuatorwhich is coupled to a filament tube disposed about the filaments in theouter housing thereby proximally retracting the filament tube andpushing at least one filament lock in an expanded state off the distalend of the filament tube and onto the filaments.
 70. The method of claim69 wherein the filament lock comprises a self-contracting configurationand further comprising allowing the self-contracting filament lock tocontract to a relaxed state over the filaments thereby clamping the atleast one filament lock onto the filaments and to each other once theoutward radial support of the filament tube is removed by proximallyretracting the distal end of the filament tube past a distal shoulder ofa close fitting bore disposed about the distal end of the filament tube.71. The method of claim 56 further comprising cutting the filamentsproximal of the deployed filament lock by actuating a filament cutter ofthe actuator assembly which is disposed in operative arrangement withthe filaments.
 72. The method of claim 56 wherein a sharpened blade ofthe filament cutter is disposed in a slide and wherein actuating thefilament cutter of the actuator assembly comprises translating the slideand sharpened blade in a bore of relative to the filaments andapproximating the filaments during transverse translation and contactingthe filaments thereby cutting through the filaments.
 73. A vascularclosure device, comprising: a filament lock comprising a tubularstructure with a main body portion and a plurality of fingers extendingproximally from the main body portion, the fingers being of sufficientaxial length and elastically biased towards a center longitudinal axisof the main body portion such that respective distal ends of the fingersare configured to be self-contracting from an expanded state to arelaxed state and clamp onto the filaments disposed within the innerlumen of the filament lock when the fingers are in the relaxed state andthe fingers may be elastically spread to a relative transverseseparation to the expanded state sufficient to fit onto an outer surfaceof the distal end of a filament tube; a filament tube disposed withinthe inner lumen of the filament lock with the filament lock in theexpanded state; at least one filament disposed within the inner lumen ofthe filament lock; and a filament tube actuator which is configured toaxially withdraw the filament tube from within the inner lumen of thefilament lock.
 74. The vascular closure assembly of claim 73 wherein thefilament lock comprises about 3 fingers to about 10 fingers.
 75. Thevascular closure assembly of claim 74 wherein the filament lockcomprises about 4 fingers to about 6 fingers.
 76. The vascular closureassembly of claim 73 wherein the filament lock comprises a superelasticmaterial.
 77. The vascular closure assembly of claim 76 wherein thesuperelastic material of the filament lock comprises nickel titaniumalloy.
 78. A method for vascular closure, comprising: distally advancingan actuator assembly until a distal end of an elongate housing of theactuator assembly is disposed adjacent a passage in a tissue layer;deploying a plurality of anchor deployers from the elongate housing in adistal and radially outward direction in an asymmetric pattern about alongitudinal axis of the elongate housing and engaging the tissue layerin positions disposed about the passage in the tissue layer in anasymmetric deployment pattern with respective anchors of the pluralityof anchor deployers; drawing the anchors closer together by applyingtension to filaments secured to each of the respective anchors so as todraw the anchors and respective portions of the tissue layer secured toeach of the anchors together and thereby reducing a transverse dimensionof the passage in the tissue layer; and deploying a filament lock ontothe filaments at a distal end of the elongate housing while maintainingtension force on the filaments.